Hemodynamic-GUIDEd Management of Heart Failure (GUIDE-HF)

The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including heart failure (HF) patients outside of the present indication, but at risk for future HF events or mortality.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Heart Failure, Diastolic; Heart Failure, Systolic; Heart Failure NYHA Class II; Heart Failure NYHA Class III; Heart Failure With Reduced Ejection Fraction; Heart Failure NYHA Class IV; Heart Failure With Normal Ejection Fraction; Heart Failure; With Decompensation; Heart Failure，Congestive
• Intervention / Treatment: Device: CardioMEMS™ HF System

Detailed Description

The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including HF patients outside of the present indication, but at risk for future HF events or mortality.

The trial includes patients with New York Heart Association (NYHA) Class II, III, or IV HF who have an elevated N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or an elevated Brain Natriuretic Peptide (BNP)) and/or a prior HF hospitalization (HFH).

The GUIDE-HF IDE trial will include approximately 3600 subjects at approximately 140 North American sites and consists of two arms: a Randomized Arm and a Single Arm.

• Study Type: Interventional
• Enrollment (Actual): 2358
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N2T9
      • Foothills Medical Centre
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital (U of BC)
  • Ontario
    • Newmarket, Ontario, Canada, L3Y 2P9
      • Southlake Regional Health Centre
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner-University Medical Center Phoenix
    • Phoenix, Arizona, United States, 85016
      • Arizona Cardiovascular Research Center
    • Phoenix, Arizona, United States, 85018
      • Phoenix Cardiovascular Research Group
    • Tucson, Arizona, United States, 85719
      • University of Arizona
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Washington Regional Medical Center
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Heart Hospital
    • Little Rock, Arkansas, United States, 72205
      • Baptist Health Medical Center
  • California
    • Concord, California, United States, 94520
      • John Muir Medical Center
    • Deer Park, California, United States, 94574
      • Adventist Health St. Helena
    • La Jolla, California, United States, 92037
      • Scripps Health
    • La Jolla, California, United States, 92037
      • University of California at San Diego (UCSD) Medical Center
    • Los Angeles, California, United States, 90095
      • Ronald Reagan UCLA Medical Center
    • Los Angeles, California, United States, 90033
      • USC University Hospital
    • Rancho Mirage, California, United States, 92270
      • Eisenhower Medical Center
    • Sacramento, California, United States, 95819
      • Mercy Medical Group - Cardiology
    • Sacramento, California, United States, 95816
      • Sutter Medical Center, Sacramento
    • San Diego, California, United States, 92123
      • San Diego Cardiac Center
    • San Francisco, California, United States, 94109
      • California Pacific Medical Center - Van Ness Campus
    • Ventura, California, United States, 93003
      • Ventura Cardiology Consultants
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital
    • Greeley, Colorado, United States, 80631
      • North Colorado Medical Center
    • Littleton, Colorado, United States, 80120
      • South Denver Cardiology Associates PC
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Hartford Hospital
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University Hospital
  • Florida
    • Boynton Beach, Florida, United States, 33466
      • Bethesda Memorial Hospital
    • Clearwater, Florida, United States, 33756
      • Morton Plant Hospital
    • Hollywood, Florida, United States, 33020
      • Memorial Regional Hospital
    • Jacksonville, Florida, United States, 32216
      • First Coast Cardiovascular Institute
    • Jacksonville, Florida, United States, 32216
      • Memorial Hospital Jacksonville
    • Orlando, Florida, United States, 32803
      • Advent Health Orlando
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Georgia
    • Athens, Georgia, United States, 30606
      • Piedmont Athens Regional Medical Center
    • Augusta, Georgia, United States, 30901
      • University Hospital
    • Marietta, Georgia, United States, 30060
      • Wellstar Kennestone Hospital
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Northshore University Healthsystem
    • Oakbrook Terrace, Illinois, United States, 60181
      • Advocate Health and Hospitals Corporation
  • Indiana
    • Indianapolis, Indiana, United States, 46240
      • St. Vincent Hospital
    • Merrillville, Indiana, United States, 46410
      • Heart Center of Lake County
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Iowa Heart Center
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Kansas University Medical Center
    • Wichita, Kansas, United States, 67226
      • Cardiovascular Research Institute of Kansas
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Our Lady of the Lake Hospital
    • Houma, Louisiana, United States, 70361
      • Cardiovascular Institute of the South
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center
    • New Orleans, Louisiana, United States, 70112
      • Louisiana State University Health Sciences Center
    • Shreveport, Louisiana, United States, 71105
      • Advanced Cardiovascular Specialists
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • University of Michigan
    • Auburn Hills, Michigan, United States, 48326
      • McLaren Health Care Corporation
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Midland, Michigan, United States, 48640
      • MidMichigan Medical Center-Midland
    • Southfield, Michigan, United States, 48075
      • Providence Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Medical Center Fairview
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
    • Saint Cloud, Minnesota, United States, 56303
      • St. Cloud Hospital
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Hospital
    • North Kansas City, Missouri, United States, 64116
      • North Kansas City Hospital
    • Saint Louis, Missouri, United States, 63141
      • Mercy Hospital St. Louis
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • BryanLGH Heart Institute
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • Nevada
    • Reno, Nevada, United States, 89502
      • Renown Regional Medical Center
  • New Hampshire
    • Manchester, New Hampshire, United States, 03102
      • Catholic Medical Center
  • New Jersey
    • Browns Mills, New Jersey, United States, 08015
      • Deborah Heart and Lung Center
    • Livingston, New Jersey, United States, 07039
      • Saint Barnabas Medical Center
    • Voorhees, New Jersey, United States, 08043
      • Lourdes Cardiology Services
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • New Mexico Heart Institute
  • New York
    • New York, New York, United States, 10016
      • New York University Hospital
    • New York, New York, United States, 10019
      • Mount Sinai Hospital
    • New York, New York, United States, 10032
      • New York-Presbyterian/Columbia University
    • Poughkeepsie, New York, United States, 12601
      • Hudson Valley Cardiovascular Practice, P.C.
    • Rochester, New York, United States, 14621
      • Rochester General Hospital
    • Roslyn, New York, United States, 11576
      • St. Francis Hospital
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
    • Greenville, North Carolina, United States, 27835
      • Vidant Medical Center
    • Raleigh, North Carolina, United States, 27607
      • NC Heart and Vascular Research
    • Raleigh, North Carolina, United States, 27610
      • WakeMed Hospital
  • Ohio
    • Akron, Ohio, United States, 44309
      • Akron City Hospital
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43210
      • Ohio State University
    • Columbus, Ohio, United States, 43214
      • Ohio Health Research Institute
    • Youngstown, Ohio, United States, 44501
      • St. Elizabeth Health Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • INTEGRIS Baptist Medical Center
    • Oklahoma City, Oklahoma, United States, 73135
      • Oklahoma Heart Hospital South
    • Tulsa, Oklahoma, United States, 74133
      • Oklahoma Heart Institute at Utica
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence Heart and Vascular
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Abington Memorial Hospital
    • Harrisburg, Pennsylvania, United States, 17105
      • Pinnacle Health System
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center
    • Lancaster, Pennsylvania, United States, 17603
      • Lancaster General Hospital
    • Philadelphia, Pennsylvania, United States, 19141
      • Albert Einstein Medical Center
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital - ASRI
    • West Reading, Pennsylvania, United States, 19611
      • The Reading Hospital and Medical Center
    • Wynnewood, Pennsylvania, United States, 19096
      • Main Line Health Center/Lankenau Hospital
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Prisma Health-Midlands
    • Greenville, South Carolina, United States, 29605
      • Greenville Health System
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57117
      • Sanford USD Medical Center
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Tennova Healthcare - Turkey Creek Medical Center
    • Memphis, Tennessee, United States, 38104
      • Methodist University Hospital
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States, 37205
      • St Thomas Hospital
  • Texas
    • Austin, Texas, United States, 78756
      • Austin Heart
    • Austin, Texas, United States, 78705
      • Acension Texas Cardiovascular
    • Dallas, Texas, United States, 75246
      • Baylor University Hospital
    • Fort Worth, Texas, United States, 76104
      • John Peter Smith Hospital
    • Houston, Texas, United States, 77030
      • The Methodist Hospital
    • Houston, Texas, United States, 77030
      • Memorial Hermann Hospital
    • Houston, Texas, United States, 77004
      • Park Plaza Hospital
    • Houston, Texas, United States, 77030
      • CHI St. Luke's Health Baylor College of Medicine Med. Ctr.
    • San Antonio, Texas, United States, 78229
      • Methodist Healthcare System of San Antonio
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Virginia Heart - The Cardiovascular Group, P.C.
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
    • Richmond, Virginia, United States, 23226
      • Bon Secours Heart & Vascular Institute
    • Winchester, Virginia, United States, 22601
      • Winchester Medical Center
  • Washington
    • Everett, Washington, United States, 98206
      • Providence Everett Medical Center
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center - Heart & Vascular
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Medical Group
    • Waukesha, Wisconsin, United States, 53188
      • Waukesha Memorial Hospital
    • Wausau, Wisconsin, United States, 54401
      • Aspirus Wausau Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnosis and treatment for heart failure (HF) (regardless of left ventricular ejection fraction (LVEF)) for > 90 days prior to the date of consent:

   a. Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current American Heart Association (AHA)/American College of Cardiology (ACC) guidelines as standard-of-care for HF therapy in the United States, with any intolerance documented.

2. GUIDE-HF Randomized Arm Only: NYHA Class II, III or IV HF symptoms documented within 30 days prior to consent.
3. GUIDE-HF Single Arm Only: NYHA Class III HF symptoms documented within 30 days prior to consent.

4. HF hospitalization (HFH) within 12 months prior to consent and/or elevated N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or Brain Natriuretic Peptide (BNP)) within 30 days prior to consent defined as:

   1. Subjects with LVEF ≤ 40%: NT-proBNP ≥ 1000 pg/mL (or BNP ≥ 250 pg/mL).
   2. Subjects with LVEF > 40%: NT-proBNP ≥ 700 pg/mL (or BNP ≥ 175 pg/mL).
   3. Thresholds for NT-proBNP and BNP (for both LVEF ≤ 40% and LVEF > 40%) will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 25 kg/m2
5. ≥ 18 years of age
6. Chest circumference of < 65 inches, if BMI is > 35 kg/m2
7. Written informed consent obtained from subject
8. Willing and able to upload pulmonary artery (PA) pressure information and comply with the follow-up requirements

Exclusion Criteria:

1. Intolerance to all neuro-hormonal antagonists (i.e., intolerance to angiotensin converting enzyme-inhibitors (ACE-I), angiotensin receptor blockers (ARB), angiotensin-neprilysin inhibitors (ARNi), hydralazine/isosorbide dinitrate and beta-blockers)
2. ACC/AHA Stage D refractory HF (including having received or currently receiving pharmacologic circulatory support with inotropes)
3. Received or are likely to receive an advanced therapy (e.g., mechanical circulatory support or cardiac transplant) in the next 12 months

4. NYHA Class IV HF patients with:

   1. Continuous or chronic use of scheduled intermittent inotropic therapy for HF and an INTERMACS level of ≤ 4, OR
   2. Persistence of fluid overload with maximum (or dose equivalent) diuretic intervention
5. Glomerular Filtration Rate (eGFR) < 25 mL/min and non-responsive to diuretic therapy, or receiving chronic dialysis
6. Inability to tolerate or receive dual antiplatelet therapy or anticoagulation therapy for one month post-implantation
7. Significant congenital heart disease that has not been repaired and would prevent implantation of the CardioMEMS™ PA Sensor
8. Implanted with mechanical right heart valve(s)
9. Unrepaired severe valvular disease
10. Pregnant or planning to become pregnant in the next 12 months
11. An active, ongoing infection, defined as being febrile, an elevated white blood cell count, on intravenous antibiotics, and/or positive cultures (blood, sputum or urine).
12. History of current or recurrent (≥ 2 episodes within 5 years prior to consent) pulmonary emboli and/or deep vein thrombosis
13. Major cardiovascular event (e.g., unstable angina, myocardial infarction, percutaneous coronary intervention, open heart surgery, or stroke, etc.) within 90 days prior to consent
14. Implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) for less than 90 days prior to consent
15. Enrollment into another trial with an active treatment arm
16. Anticipated life expectancy of < 12 months
17. Any condition that, in the opinion of the Investigator, would not allow for utilization of the CardioMEMS™ HF System to manage the subject using information gained from hemodynamic measurements to adjust medications, including the presence of unexpectedly severe pulmonary hypertension (e.g., trans-pulmonary gradient >15) at implant right heart catheterization (RHC), a history of non-compliance, or any condition that would preclude CardioMEMS™ PA Sensor implantation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Randomized Arm - Treatment Group; Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System.	Device: CardioMEMS™ HF System; The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.; Other Names: CardioMEMS; CardioMEMS PA Sensor; CardioMEMS HF System
Experimental: Randomized Arm - Control Group; Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System.	Device: CardioMEMS™ HF System; The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.; Other Names: CardioMEMS; CardioMEMS PA Sensor; CardioMEMS HF System
Experimental: Single Arm; Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System.	Device: CardioMEMS™ HF System; The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.; Other Names: CardioMEMS; CardioMEMS PA Sensor; CardioMEMS HF System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality	The composite of: The number of recurrent heart failure hospitalizations (HFHs); The number of heart failure (HF) emergency department/hospital outpatient observation visits for intravenous diuretic therapy (ED/OP); The number of deaths of any cause added together with equal weighting into a total number of events	12 months post-implantation (395 days after implant date)
(Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis]	The composite of: The number of recurrent heart failure hospitalizations (HFHs); The number of heart failure (HF) emergency department/hospital outpatient observation visits for intravenous diuretic therapy (ED/OP); The number of deaths of any cause added together with equal weighting into a total number of events.	The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months).
(Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis]	The composite of: The number of recurrent heart failure hospitalizations (HFHs); The number of heart failure (HF) emergency department/hospital outpatient observation visits for intravenous diuretic therapy (ED/OP); The number of deaths of any cause added together with equal weighting into a total number of events.	12 Months Post Implantation
(Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis]	The composite of: The number of recurrent heart failure hospitalizations (HFHs); The number of heart failure (HF) emergency department/hospital outpatient observation visits for intravenous diuretic therapy (ED/OP); The number of deaths of any cause added together with equal weighting into a total number of events.	12 Months Post-Implantation
(Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality	The composite outcome of: The number of recurrent heart failure hospitalizations (HFHs); The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy; The number of deaths of any cause added together with equal weighting into a total number of events	12 months post-implantation (395 days after implant date)
(Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis]	The composite outcome of: The number of recurrent heart failure hospitalizations (HFHs); The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy; The number of deaths of any cause added together with equal weighting into a total number of events	Events were analyzed through March 13, 2020 for pre-COVID-19 analysis (median follow-up: 5.4 months) and from March 13, 2020 through the end of subject's follow-up for during COVID-19 analysis (median follow-up: 11.2 months).
(Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis]	The composite outcome of: The number of recurrent heart failure hospitalizations (HFHs); The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy; The number of deaths of any cause added together with equal weighting into a total number of events	12 Months Post Implantation
(Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis]	The composite outcome of: The number of recurrent heart failure hospitalizations (HFHs); The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy; The number of deaths of any cause added together with equal weighting into a total number of events	12 Months Post Implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(Randomized Arm) 6MHW Test	Six Minute Hall Walk (6MHW) Test Distance	Baseline, 6, and 12 months post-implantation
(Randomized Arm) HFHs	The number of recurrent HFHs	12 months post-implantation
(Single Arm) HFHs	The number of HFHs	12 months post-implantation
(Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits	The composite outcome of: The number of recurrent heart failure hospitalizations (HFHs); The number of emergency department/hospital outpatient observation visits (ED/OP) for intravenous diuretic therapy added together with equal weighting into a total number of events	12 months post-implantation
(Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis)	The composite outcome of: The number of recurrent heart failure hospitalizations (HFHs); The number of emergency department/hospital outpatient observation visits (ED/OP) for intravenous diuretic therapy added together with equal weighting into a total number of events	The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months).
(Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis)	The composite outcome of: The number of recurrent heart failure hospitalizations (HFHs); The number of emergency department/hospital outpatient observation visits (ED/OP) for intravenous diuretic therapy added together with equal weighting into a total number of events	12 Months Post Implantation
(Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis)	The composite outcome of: The number of recurrent heart failure hospitalizations (HFHs); The number of emergency department/hospital outpatient observation visits (ED/OP) for intravenous diuretic therapy added together with equal weighting into a total number of events	12 Months Post Implantation
(Randomized Arm) HFHs [Follow-up Based COVID-19 Sensitivity Analysis]	The number of recurrent HFHs	The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months).
(Randomized Arm) HFHs [Subject Based COVID-19 Sensitivity Analysis]	The number of recurrent HFHs	12 Months Post-Implantation
(Randomized Arm) HFHs [Event Based COVID-19 Sensitivity Analysis]	The number of recurrent HFHs	12 Months Post Implantation
(Randomized Arm) Intravenous Diuretic Visits	The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy	12 months post-implantation
(Randomized Arm) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis]	The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy	The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months).
(Randomized Arm) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis]	The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy	12 Months Post Implantation
(Randomized Arm) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis]	The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy	12 Months Post-Implantation
(Randomized Arm) All-cause Mortality	The number of deaths of any cause	12 months post-implantation
(Randomized Arm) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis]	The number of deaths of any cause	The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months).
(Randomized Arm) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis]	The number of deaths of any cause	12 Months Post-Implantation
(Randomized Arm) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis]	The number of deaths of any cause	12 Months Post-Implantation
(Randomized Arm) KCCQ-12	Health status as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated health-related quality of life measure for heart failure and was qualified by the FDA as a medical device development tool in 2017. The KCCQ-12 quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life over a scale from 0 to 100. An overall summary score (OSS) is derived by averaging scores from each domain, with a higher score reflecting a better health status. Change from baseline KCCQ-12 scores were evaluated at 6 and 12-month visits.	Baseline, 6, and 12 months post-implantation
(Randomized Arm) KCCQ-12 (Subject Based COVID-19 Sensitivity Analysis)	Health status as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated health-related quality of life measure for heart failure and was qualified by the FDA as a medical device development tool in 2017. The KCCQ-12 quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life over a scale from 0 to 100. An overall summary score (OSS) is derived by averaging scores from each domain, with a higher score reflecting a better health status. Descriptive statistics of KCCQ-12 scores at baseline, 6 and 12-month visits were reported.	Baseline, 6, and 12 months post-implantation
(Randomized Arm) EQ-5D-5L	Health status as assessed by the EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Questionnaire The EQ-5D-5L Questionnaire is a standardized measure of health status that consists of a descriptive system and a visual analog score (VAS). The VAS records the subject's self-rated health status which ranges from a score of 0 (worst health you can imagine) to 100 (best health you can imagine). A higher VAS score represents a better quality of life.	Baseline, 6, and 12 months post-implantation
(Randomized Arm) EQ-5D-5L (Subject Based COVID-19 Sensitivity Analysis)	Health status as assessed by the EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Questionnaire The EQ-5D-5L Questionnaire is a standardized measure of health status that consists of a descriptive system and a visual analog score (VAS). The VAS records the subject's self-rated health status which ranges from a score of 0 (worst health you can imagine) to 100 (best health you can imagine). A higher VAS score represents a better quality of life.	Baseline, 6, and 12 months post-implantation
(Randomized Arm) 6MHW Test (Subject Based COVID-19 Sensitivity Analysis)	Six Minute Hall Walk (6MHW) Test Distance	Baseline, 6, and 12 months post-implantation
(Randomized Arm) Safety: Freedom From DSRCs	Freedom from device/system related complications (DSRCs)	12 months post-implantation
(Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits	The composite outcome of: The number of recurrent HFHs; The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy added together with equal weighting into a total number of events	12 months post-implantation
(Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis]	The composite outcome of: The number of recurrent HFHs; The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy added together with equal weighting into a total number of events	Events were analyzed through March 13, 2020 for pre-COVID-19 analysis (median follow-up: 5.4 months) and from March 13, 2020 through the end of subject's follow-up for during COVID-19 analysis (median follow-up: 11.2 months).
(Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis]	The composite outcome of: The number of recurrent HFHs; The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy added together with equal weighting into a total number of events	12 Months Post Implantation
(Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis]	The composite outcome of: The number of recurrent HFHs; The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy added together with equal weighting into a total number of events	12 Months Post Implantation
(Single Arm) Intravenous Diuretic Visits	The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy	12 months post-implantation
(Single Arm) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis]	The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy	Events were analyzed through March 13, 2020 for pre-COVID-19 analysis (median follow-up: 5.4 months) and from March 13, 2020 through the end of subject's follow-up for during COVID-19 analysis (median follow-up: 11.2 months).
(Single Arm) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis]	The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy	12 months post-implantation
(Single Arm) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis]	The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy	12 Months Post Implantation
(Single Arm) HFHs [Follow-Up Based COVID-19 Sensitivity Analysis]	The number of heart failure hospitalizations (HFHs)	Events were analyzed through March 13, 2020 for pre-COVID-19 analysis (median follow-up: 5.4 months) and from March 13, 2020 through the end of subject's follow-up for during COVID-19 analysis (median follow-up: 11.2 months).
(Single Arm) HFHs [Subject Based COVID-19 Sensitivity Analysis]	The number of heart failure hospitalizations (HFHs)	12 Months Post Implantation
(Single Arm) HFHs [Event Based COVID-19 Sensitivity Analysis]	The number of heart failure hospitalizations (HFHs)	12 Months Post Implantation
(Single Arm) All-cause Mortality	The number of deaths of any cause	12 months post-implantation
(Single Arm) All-cause Mortality [Follow-Up Based COVID-19 Sensitivity Analysis]	The number of deaths of any cause	Events were analyzed through March 13, 2020 for pre-COVID-19 analysis (median follow-up: 5.4 months) and from March 13, 2020 through the end of subject's follow-up for during COVID-19 analysis (median follow-up: 11.2 months).
(Single Arm) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis]	The number of deaths of any cause	12 Months Post Implantation
(Single Arm) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis]	The number of deaths of any cause	12 Months Post Implantation
(Single Arm) Safety: Freedom From DSRCs	Proportion of subjects with freedom from device/system related complications (DSRCs)	12 months post-implantation
(Single Arm) HFHs Post- vs. Pre-implantation [Elevated NT-proBNP/BNP Only Group]	The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation	12 months post-implantation vs 12 months pre-implantation
(Single Arm) HFHs Post- vs. Pre-implantation [Previous HF Hospitalization Only Group]	The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation	12 months post-implantation vs 12 months pre-implantation
(Single Arm) HFHs Post- vs. Pre-implantation [Elevated NT-proBNP/BNP and Previous HF Hospitalization Group]	The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation	12 months post-implantation vs 12 months pre-implantation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
(Randomized Arm) Cardiovascular Mortality	The number of deaths with cardiovascular cause	12 months post-implantation
(Randomized Arm) All-cause Hospitalizations	The number of hospitalizations of any cause	12 months post-implantation
(Randomized Arm) Frequency of Subject PA Pressure Uploads	The frequency of subject uploads of PA pressure	12 months post-implantation
(Randomized Arm) HF Medication Changes	The number of changes in HF medications	12 months post-implantation
(Randomized Arm) PA Pressure Measurements [Mixed Model Analysis]	Changes in PA pressure relative to baseline for systolic, diastolic, and mean PA pressures analyzed using a mixed linear model at fixed time points (Baseline, 6 months, and 12 months) producing least-squares means.	Baseline through 12 months post-implantation
(Randomized Arm) PA Pressure Measurements [AUC Analysis]	Changes in PA pressure relative to baseline for systolic, diastolic, and mean PA pressures analyzed using an area under the curve (AUC) analysis of change from baseline on all PA pressure readings through 12 months.	Baseline through 12 months post-implantation
(Randomized Arm) BNP	Change in BNP measurements from baseline	6 months post-implantation
(Randomized Arm) BNP	Change in BNP measurements from baseline	12 months post-implantation
(Randomized Arm) NT-proBNP	Change in NT-proBNP measurements from baseline	6 months post-implantation
(Randomized Arm) NT-proBNP	Change in NT-proBNP measurements from baseline	12 months post-implantation
(Randomized Arm) HFHs Post- vs. Pre-implantation [Treatment Group]	The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation in the Treatment group	12 months post-implantation vs 12 months pre-implantation
(Randomized Arm) HFHs Post- vs. Pre-implantation [Control Group]	The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation	12 months post-implantation vs 12 months pre-implantation
(Single Arm) KCCQ-12 [Mixed Model Analysis]	Health status as assessed by the KCCQ-12 The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated health-related quality of life measure for heart failure and was qualified by the FDA as a medical device development tool in 2017. The KCCQ-12 quantifies physical function, symptoms (frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life on a scale from 0 to 100. An overall summary score (OSS) is derived by averaging scores from each domain, with a higher score reflecting a better health status.	6 months post-implantation
(Single Arm) KCCQ-12 [Mixed Model Analysis]	Health status as assessed by the KCCQ-12 The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated health-related quality of life measure for heart failure and was qualified by the FDA as a medical device development tool in 2017. The KCCQ-12 quantifies physical function, symptoms (frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life on a scale from 0 to 100. An overall summary score (OSS) is derived by averaging scores from each domain, with a higher score reflecting a better health status.	12 months post-implantation
(Single Arm) EQ-5D-5L [Mixed Model Analysis]	Health status as assessed by the EQ-5D-5L Questionnaire. The data represents the EQ Visual Analogue Scale (VAS) subscale. The VAS records the subject's self-rated health status which ranges from a score of 0 (worst health you can imagine) to 100 (best health you can imagine). A higher VAS score for represents a better quality of life.	6 months post-implantation
(Single Arm) EQ-5D-5L [Mixed Model Analysis]	Health status as assessed by the EQ-5D-5L Questionnaire. The data represents the EQ Visual Analogue Scale (VAS) subscale. The VAS records the subject's self-rated health status which ranges from a score of 0 (worst health you can imagine) to 100 (best health you can imagine). A higher VAS score for represents a better quality of life.	12 months post-implantation
(Single Arm) 6MHW Test [Mixed Model Analysis]	6MHW Test Distance	6 months post-implantation
(Single Arm) 6MHW Test [Mixed Model Analysis]	6MHW Test Distance	12 months post-implantation
(Single Arm) Cardiovascular Mortality	The number of deaths of cardiovascular cause	12 months post-implantation
(Single Arm) All-cause Hospitalizations	The number of hospitalizations of any cause	12 months post-implantation
(Single Arm) Frequency of Subject PA Pressure Uploads - Daily Compliance	The frequency of subject uploads of PA pressure	12 months post-implantation
(Single Arm) Frequency of Subject PA Pressure Uploads - Weekly Compliance	The frequency of subject uploads of PA pressure	12 months post-implantation
(Single Arm) HF Medication Changes	The number of changes in HF medications	12 months post-implantation
(Single Arm) PA Pressure Measurements [Mixed Model Analysis]	Changes in PA pressure relative to baseline for systolic, diastolic, and mean PA pressures analyzed using a mixed linear model at fixed time points (Baseline, 6 months, and 12 months) producing least-squares means.	Baseline through 12 months post-implantation
(Single Arm) PA Pressure Measurements [AUC Analysis]	Changes in PA pressure relative to baseline for systolic, diastolic, and mean PA pressures analyzed using area under the curve (AUC) analysis of PA pressure across the full follow-up period	Baseline through 12 months post-implantation
(Single Arm) NT-proBNP (or BNP) [Mixed Model Analysis]	Either change in N-terminal pro-brain natriuretic peptide (NT-proBNP) or Brain natriuretic peptide (BNP) measurements at 6 months visits from baseline.	6 months post-implantation
(Single Arm) NT-proBNP (or BNP) [Mixed Model Analysis]	Either change in N-terminal pro-brain natriuretic peptide (NT-proBNP) or Brain natriuretic peptide (BNP) measurements at 6 months and 12 months visits from baseline.	12 months post-implantation

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Nessa Johnson, PhD, Abbott

Publications and helpful links

General Publications

• Zile MR, Desai AS, Costanzo MR, Ducharme A, Maisel A, Mehra MR, Paul S, Sears SF, Smart F, Chien C, Guha A, Guichard JL, Hall S, Jonsson O, Johnson N, Sood P, Henderson J, Adamson PB, Lindenfeld J. The GUIDE-HF trial of pulmonary artery pressure monitoring in heart failure: impact of the COVID-19 pandemic. Eur Heart J. 2022 Jul 14;43(27):2603-2618. doi: 10.1093/eurheartj/ehac114.
• Lindenfeld J, Zile MR, Desai AS, Bhatt K, Ducharme A, Horstmanshof D, Krim SR, Maisel A, Mehra MR, Paul S, Sears SF, Sauer AJ, Smart F, Zughaib M, Castaneda P, Kelly J, Johnson N, Sood P, Ginn G, Henderson J, Adamson PB, Costanzo MR. Haemodynamic-guided management of heart failure (GUIDE-HF): a randomised controlled trial. Lancet. 2021 Sep 11;398(10304):991-1001. doi: 10.1016/S0140-6736(21)01754-2. Epub 2021 Aug 27.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2018
• Primary Completion (Actual): May 17, 2023
• Study Completion (Actual): May 17, 2023

Study Registration Dates

• First Submitted: December 12, 2017
• First Submitted That Met QC Criteria: December 22, 2017
• First Posted (Actual): January 2, 2018

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: July 18, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Heart Failure; Pulmonary Artery Pressure; Hemodynamic Monitoring; CardioMEMS
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Heart Failure, Diastolic; Heart Failure, Systolic
• Other Study ID Numbers: CIP-10170

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes