Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure (TEAM-HF)

June 8, 2026 updated by: Abbott Medical Devices
The purpose of TEAM-HF IDE clinical trial is to evaluate safety and effectiveness of the HeartMate 3 LVAS compared to guideline directed medical therapy (GDMT) in a population of ambulatory advanced heart failure patients who are not dependent on intravenous inotrope.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients with heart failure (HF) suffer from a high degree of morbidity and mortality. Left ventricular assist device (LVAD) therapy has become the standard of care for the treatment of advanced HF patients who are deemed to be dependent on continuous intravenous inotropes, extending life expectancy, enhancing overall quality of life, and improving functional capacity. However, use of LVADs in ambulatory, non-inotrope dependent advanced HF population is limited. Elevated mean pulmonary artery pressure (PAP) secondary to left ventricular failure has emerged as a potential predictor of increased mortality risk for patients refractory to maximally tolerated guideline directed medical therapy (GDMT). In these patients, left ventricular failure with elevated mean PAP may represent objective criteria to identify advanced HF patients requiring heart replacement therapies such as LVAD.

The TEAM-HF IDE trial will enroll approximately 850 subjects with New York Heart Association (NYHA) Class IIIB/IV HF who had a prior heart failure hospitalization and an elevated mean PAP secondary to left ventricular failure. Elevated mean PAP will be identified using an implanted PAP monitoring sensor, the CardioMEMS PA Sensor. All subjects enrolled can have a previously implanted CardioMEMS PA Sensor or, if not, will be implanted with the CardioMEMS PA Sensor after enrollment. The overall objectives of TEAM-HF trial are two-fold: 1) To determine whether PAP can objectively identify patients most at risk for worsening HF and therefore most likely to benefit from earlier intervention with LVAD therapy and 2) To determine the benefit of LVAD therapy in non-inotrope advanced HF patients with elevated mean PAP refractory to GDMT.

The trial will include approximately 75 global sites and consists of a Randomized Arm and a Single Arm Registry.

The TEAM-HF Randomized Arm is a prospective, randomized, open-label study of the HeartMate 3 (HM3) left ventricular assist system (LVAS) versus continued GDMT in non-inotrope dependent HF patients. The objectives of the Randomized Arm are 1) To establish an objective disease-state criteria to trigger referral for a HM3 LVAS and 2) Demonstrate improvement in survival when non-inotrope dependent advanced HF patients are treated with the HM3 LVAS compared to being managed on medical therapy alone.

The TEAM-HF Single Arm Registry is a prospective, single-arm, open-label study of non-inotrope dependent HF patients who do not meet a mean PAP threshold after GDMT optimization. The objective of the Single Arm Registry is to characterize the progression of patients with non-inotrope dependent HF without elevated PAP.

Study Type

Interventional

Enrollment (Estimated)

850

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
    • State of Vienna
      • Vienna, State of Vienna, Austria, 1090
        • Recruiting
        • AKH -Wien
        • Contact:
        • Principal Investigator:
          • Daniel Zimpfer, MD
  • Czechia
    • CBohmia
      • Prague, CBohmia, Czechia, 14021
        • Recruiting
        • IKEM Prague
        • Principal Investigator:
          • Ivan Netuka, MD
        • Contact:
  • Denmark
    • Copenhagen
      • Copenhagen, Copenhagen, Denmark, 2100
        • Recruiting
        • Rigshospitalet
        • Contact:
        • Principal Investigator:
          • Kasper Rossing, MD
  • Germany
    • Saxon
      • Hanover, Saxon, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover
        • Principal Investigator:
          • Dominik Berliner, MD
        • Contact:
    • Saxony
    • State of Berlin
      • Berlin, State of Berlin, Germany, 13353
        • Recruiting
        • Deutsches Herzzentrum der Charité
        • Principal Investigator:
          • Felix Schoenrath, MD
        • Contact:
  • Italy
    • Piedmont
      • Turin, Piedmont, Italy, 10126
        • Recruiting
        • A.O.U. Città della Salute e Della Scienza di Torino
        • Contact:
        • Principal Investigator:
          • Antonino Loforte, MD
  • Netherlands
    • Holland
      • Rotterdam, Holland, Netherlands, 3015 CE
        • Recruiting
        • Erasmus MC - Thoraxcenter
        • Contact:
        • Principal Investigator:
          • Rudolf De Boer, MD
    • Utrecht
      • Utrecht, Utrecht, Netherlands, 3584 CX
        • Recruiting
        • UMC Utrecht
        • Principal Investigator:
          • Linda Van Laake, MD
        • Contact:
  • Saudi Arabia
    • Riyadh Region
      • Riyadh, Riyadh Region, Saudi Arabia, 11525
        • Recruiting
        • King Fahad Medical City
        • Principal Investigator:
          • Mohammed Alreshidan, MD
        • Contact:
      • Riyadh, Riyadh Region, Saudi Arabia, 12713
        • Recruiting
        • King Faisal Specialist Hospital
        • Contact:
        • Principal Investigator:
          • Jehad Abdulhamid Al Buraiki, MD
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Banner-University Medical Center Phoenix
        • Principal Investigator:
          • Radha Gopalan, MD
        • Contact:
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • Baptist Health Medical Center
        • Principal Investigator:
          • Patrick Campbell, MD
        • Contact:
    • California
      • Sacramento, California, United States, 95816
        • Recruiting
        • Sutter Medical Center
        • Contact:
        • Principal Investigator:
          • Michael Gibson, MD
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California at San Francisco
        • Contact:
        • Principal Investigator:
          • Shweta Motiwala, MD
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • Washington Hospital Center
        • Principal Investigator:
          • Sheikh Farooq, MD
        • Contact:
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • Shands at the University of Florida
        • Principal Investigator:
          • Mustafa Ahmed, MD
        • Contact:
      • Weston, Florida, United States, 33331
        • Recruiting
        • Cleveland Clinic Florida
        • Contact:
        • Principal Investigator:
          • Mauricio Velez, MD
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Heart Institute
        • Principal Investigator:
          • Catherine Marti, MD
        • Contact:
      • Augusta, Georgia, United States, 30901
        • Recruiting
        • Piedmont Augusta Hospital
        • Principal Investigator:
          • Darshak Karia, MD
        • Contact:
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Wellstar Kennestone Hospital
        • Principal Investigator:
          • Abdul Bikak, MD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago
        • Contact:
        • Principal Investigator:
          • Nikhil Narang, MD
      • Oakbrook Terrace, Illinois, United States, 60181
        • Recruiting
        • Advocate Health & Hospitals Corporation
        • Contact:
        • Principal Investigator:
          • Vinh Chau, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46240
        • Recruiting
        • St. Vincent Hospital
        • Contact:
        • Principal Investigator:
          • Ashwin Ravichandran, MD
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Hospitals & Clinics
        • Contact:
        • Principal Investigator:
          • Anthony Panos, MD
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • Kansas University Medical Center
        • Contact:
        • Principal Investigator:
          • Zubair Shah, MD
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University Of Kentucky
        • Contact:
        • Principal Investigator:
          • Emma Birks, MD
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Norton Hospital
        • Contact:
        • Principal Investigator:
          • Alkhalil Bassel, MD
    • Maine
      • Portland, Maine, United States, 04102
        • Recruiting
        • Maine Medical Center
        • Contact:
        • Principal Investigator:
          • Peter Kennel, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • Erin Coglianese, MD
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Contact:
        • Principal Investigator:
          • Lindsey Aurora, MD
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Spectrum Health Butterworth Hospital
        • Contact:
        • Principal Investigator:
          • Matthew Gonzalez, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Minneapolis Heart Institute
        • Principal Investigator:
          • Mosi Bennett, MD
        • Contact:
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Andrew Rosenbaum, MD
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • St. Luke's Hospital
        • Principal Investigator:
          • Timothy Fendler, MD
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
        • Principal Investigator:
          • Adam Burdorf, DO
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
        • Principal Investigator:
          • Kanika Mody, MD
        • Contact:
      • Newark, New Jersey, United States, 07112
        • Recruiting
        • Newark Beth Israel Medical Center
        • Principal Investigator:
          • Igor Gosev, MD
        • Contact:
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Recruiting
        • New Mexico Heart Institute
        • Contact:
        • Principal Investigator:
          • Eddie Brown, MD
    • New York
      • Manhasset, New York, United States, 11030
        • Recruiting
        • North Shore University Hospital
        • Contact:
        • Principal Investigator:
          • Maria Avila, MD
      • New York, New York, United States, 10032
        • Recruiting
        • New York-Presbyterian/Columbia University Medical Center
        • Contact:
        • Principal Investigator:
          • Dor Lotan, MD
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester Medical Center
        • Contact:
        • Principal Investigator:
          • Leway Chen, MD
      • The Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center - Moses Campus
        • Principal Investigator:
          • Yogita Rochlani, MD
        • Contact:
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina at Chapel Hill
        • Contact:
        • Principal Investigator:
          • William Mostertz, MD
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Carolinas Medical Center
        • Principal Investigator:
          • Sanjeev Gulati, MD
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45219
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • The Cleveland Clinic Foundation
        • Contact:
          • Barbara Gus
          • Phone Number: 216-445-6552
          • Email: gusb@ccf.org
        • Principal Investigator:
          • Michael Tong, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Recruiting
        • Integris Baptist Medical Center
        • Contact:
        • Principal Investigator:
          • Luke Cunningham, MD
      • Tulsa, Oklahoma, United States, 74104
        • Recruiting
        • Oklahoma Heart Institute at Utica
        • Contact:
        • Principal Investigator:
          • Luis David Meggo Quiroz, MD
      • Tulsa, Oklahoma, United States, 74136
        • Recruiting
        • Saint Francis Hospital
        • Principal Investigator:
          • Douglas Ensley, MD
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Principal Investigator:
          • Johannes Steiner, MD
        • Contact:
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Recruiting
        • Abington Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Alexander Shpilman, MD
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Penn State Milton S. Hershey Medical Center
        • Principal Investigator:
          • John Boehmer, MD
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania
        • Contact:
        • Principal Investigator:
          • Himabindu Vidula, MD
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny General Hospital
        • Principal Investigator:
          • Matthew Lander, MD
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Principal Investigator:
          • Arman Kilic, MD
        • Contact:
      • Columbia, South Carolina, United States, 29203
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Recruiting
        • The Stern Cardiovascular Foundation
        • Contact:
        • Principal Investigator:
          • Dmitry Yaranov, MD
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Ascension Texas Cardiovascular
        • Contact:
        • Principal Investigator:
          • Raymond Bietry, MD
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Baylor University Hospital
        • Contact:
        • Principal Investigator:
          • Cesar Guerrero-Miranda, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist
        • Contact:
        • Principal Investigator:
          • Cindy Martin, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • CHI St. Luke's Health Baylor College of Medicine Medical Center
        • Principal Investigator:
          • Ajith Nair, MD
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • UTHealth Memorial Hermann
        • Contact:
        • Principal Investigator:
          • Nathan Sriram, MD
      • Plano, Texas, United States, 75093
        • Recruiting
        • The Heart Hospital Baylor Plano
        • Contact:
        • Principal Investigator:
          • Aasim Afzal, MD
      • Temple, Texas, United States, 76508
        • Recruiting
        • Scott & White Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Yevgeniy Khariton, MD
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University of Utah Hospital
        • Principal Investigator:
          • Craig Selzman, MD
        • Contact:
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia Medical Center
        • Contact:
        • Principal Investigator:
          • Mirnela Byku, MD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Aurora Medical Group
        • Principal Investigator:
          • Nasir Sulemanjee, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subject has provided written informed consent by signing the study Informed Consent Form (ICF) prior to any clinical investigation-related procedure
  2. LVEF ≤30% and Cardiac Index ≤ 2.5 L/min/m²
  3. Limited functional status as demonstrated by 6MWT ≤ 350 m due to HF related reasons OR peak VO2 ≤ 14 mL/kg/min (or <50% of predicted peak VO2 value)
  4. NYHA Class IIIB or NYHA Class IV
  5. Subject has ≥ 1 Heart Failure Hospitalization in the last 12 months
  6. Subject is already implanted with a CardioMEMS PA Sensor OR willing to undergo a CardioMEMS PA Sensor implant
  7. Subject is willing and able to be implanted with the HM3 LVAS if randomized to HM3 Group

Randomization Criteria:

  1. Subject has been implanted with a CardioMEMS PA Sensor for at least 90 days.
  2. Subject is receiving guideline directed medical therapy with optimal doses (or documented medication contraindication or intolerance) of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or angiotensin receptor neprilysin inhibitor (if eligible), Mineralocorticoid Receptor Antagonists, Sodium-Glucose co-Transporter-2 (SGLT2) inhibitors, and diuretics for at least 30 of the last 90 days.
  3. mean PAP ≥ 30 mmHg.
  4. The subject will not be randomized if they have any other factor that represents inordinate risk for either continued GDMT or LVAD implant.

Single Arm Registry Criteria:

  1. Subject has received a CardioMEMS PA Sensor implant following enrollment in the trial.
  2. Subject is receiving guideline directed medical therapy with optimal doses (or documented medication contraindication or intolerance) of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or angiotensin receptor neprilysin inhibitor (if eligible), Mineralocorticoid Receptor Antagonists, Sodium-Glucose co-Transporter-2 (SGLT2) inhibitors, and diuretics for at least 30 of the last 90 days.
  3. mean PAP <30 mmHg

Exclusion Criteria:

  1. Subject is < 18 years of age at the time of informed consent.
  2. Dependent on IV inotrope in the last 30 days.
  3. Contra-indications to HM3 LVAS or CardioMEMS HF system.
  4. Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy.
  5. Technical obstacles to LVAD or CardioMEMS implantation which pose an inordinately high surgical risk, in the judgment of the implanter.
  6. Existence of ongoing MCS.
  7. Presence of mechanical aortic valve that will not be either converted to a bioprosthesis or oversewn at the time of LVAD implant.
  8. History of any solid organ transplant.
  9. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management.
  10. Presence of an active, uncontrolled infection.
  11. Complex congenital heart disease.
  12. Currently Pregnant or capable of becoming Pregnant and Unwilling to Use Contraception with LVAD.
  13. History of pulmonary embolism within 30 days prior to enrollment or history of recurrent (>1 episode) pulmonary embolism and/or deep vein thrombosis.
  14. Planned VAD or Bi-VAD support prior to enrollment.

  15. Presence of any one of the following risk factors for or indications of severe end organ dysfunction or failure:

    1. An INR ≥ 2.0 not due to anticoagulation therapy
    2. An eGFR < 30 mL/min/1.73 m2 and nonresponsive to diuretic therapy or receiving chronic dialysis.
    3. Biopsy proven liver cirrhosis.
    4. Need for chronic renal replacement therapy.
    5. History of severe chronic obstructive pulmonary disease (COPD) defined by Forced Expiratory Volume FEV1 < 30% predicted.
    6. History of cerebrovascular disease with significant (> 80%) uncorrected internal carotid stenosis.
    7. Significant peripheral vascular disease (PVD) accompanied by ischemic rest pain or extremity ulceration.
  16. Any condition other than HF that could limit survival to less than 24 months.
  17. Participation in any other clinical investigation with an active treatment arm that is likely to confound study results or affect the study outcome.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Randomized Arm - HM3 Group
Patients with elevated mean PAP (mean PAP ≥ 30 mmHg) and randomized to the HM3 group will receive the device within 14 days of randomization.
Device: CardioMEMS HF System
The CardioMEMS™ HF System is comprised of a lead-less and battery-less pressure sensor which remotely transmits pulmonary artery pressure measurements.
Other Names:
  • CardioMEMS
  • CardioMEMS PA Sensor
Device: HeartMate 3 Left Ventricular Assist System
The HeartMate 3 LVAS is a mechanical circulatory support pump with Full MagLev Technology that assumes some or all of the workload of the left ventricle. The HeartMate 3 LVAS is used in advanced heart failure patients needing short or long-term mechanical circulatory support.
Other Names:
  • HM3
Other: Guideline Medical Directed Therapy
Optimal doses of medical therapy per established heart failure guidelines which includes the following stable combination of Beta Blockers, ACE-inhibitors or ARB or ARNi, MRA and SGLT2 inhibitors.
Other Names:
  • GDMT
Experimental: Randomized Arm - Control Group
Patients with elevated mean PAP (mean PAP ≥ 30 mmHg) and randomized to the control group will continue their medical therapy per established heart failure guidelines.
Device: CardioMEMS HF System
The CardioMEMS™ HF System is comprised of a lead-less and battery-less pressure sensor which remotely transmits pulmonary artery pressure measurements.
Other Names:
  • CardioMEMS
  • CardioMEMS PA Sensor
Other: Guideline Medical Directed Therapy
Optimal doses of medical therapy per established heart failure guidelines which includes the following stable combination of Beta Blockers, ACE-inhibitors or ARB or ARNi, MRA and SGLT2 inhibitors.
Other Names:
  • GDMT
Experimental: Single Arm Registry
Patients who do not meet the mean PAP threshold (mean PAP <30 mmHg) and are enrolled in the single arm will continue their medical therapy per established heart failure guidelines.
Device: CardioMEMS HF System
The CardioMEMS™ HF System is comprised of a lead-less and battery-less pressure sensor which remotely transmits pulmonary artery pressure measurements.
Other Names:
  • CardioMEMS
  • CardioMEMS PA Sensor
Other: Guideline Medical Directed Therapy
Optimal doses of medical therapy per established heart failure guidelines which includes the following stable combination of Beta Blockers, ACE-inhibitors or ARB or ARNi, MRA and SGLT2 inhibitors.
Other Names:
  • GDMT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival at 2 years free of disabling stroke, reoperation to replace the device, or worsening HF requiring listing for urgent heart transplantation or mechanical circulatory support, enrollment into hospice, or dependence on IV inotropes
Time Frame: 2 years
The powered primary endpoint will be analyzed at 2 years following the Com-Nougue method and will be compared between the HM3 Group (HM3 LVAD) and the Control Group (GDMT) within the Intention-to-treat (ITT) population.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Safety Outcomes at 1-year
Time Frame: 1 year

The powered secondary endpoint of Rate of Safety Outcomes at 1-year will be evaluated within the Intention-to-treat (ITT) population against a pre-specified performance goal.

Components consist of the following:

  1. Heart failure hospitalization

  2. Major Adverse Event (MAE) including:

    • Stroke
    • Non-surgical bleeding (>14 days post implant) requiring hospitalization
    • Renal failure requiring hospitalization
    • Driveline infection requiring hospitalization
1 year
Survival at 2 years
Time Frame: 2 years
The powered secondary endpoint of survival at 2-years will be compared between the HM3 Group and the Control Group within the Intention-to-treat (ITT) population.
2 years
Quality of life score assessed with the Kansas City Cardiomyopathy Questionnaire
Time Frame: 2 years

The secondary endpoint of Quality-of-life score at 2-years will be compared between the HM3 Group and the Control Group within the Intention-to-treat (ITT) population. Additionally, the secondary endpoint of Quality of life at 2-years will be descriptively compared between the Single Arm Registry and both the HM3 Group and Control Group of the Randomized Arm separately.

The KCCQ scores are represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life. Improvement of KCCQ by at least 10 points is considered clinically significant.
2 years
Six-minute walk distance
Time Frame: 2 years
The secondary endpoint of six-minute walk distance at 2-years will be compared between the HM3 Group and the Control Group within the Intention-to-treat (ITT) population. Additionally, the secondary endpoint of six-minute walk distance at 2-years will be descriptively compared between the Single Arm Registry and both the HM3 Group and Control Group of the Randomized Arm separately.
2 years
Hospitalizations for HF and/or Urgent HF Visit
Time Frame: 2 years
The secondary endpoint of Hospitalizations for HF and/or Urgent HF Visit at 2-years will be compared between the HM3 Group and the Control Group within the Intention-to-treat (ITT) population. Additionally, the secondary endpoint of Hospitalizations for HF and/or Urgent HF Visit at 2-years will be descriptively compared between the Single Arm Registry and both the HM3 Group and Control Group of the Randomized Arm separately.
2 years
Days alive and outside of the hospital
Time Frame: 2 years
The secondary endpoint of days alive and outside of the hospital at 2-years will be compared between the HM3 Group and the Control Group within the Intention-to-treat (ITT) population. Additionally, the secondary endpoint of days alive and outside of the hospital at 2-years will be descriptively compared between the Single Arm Registry and both the HM3 Group and Control Group of the Randomized Arm separately.
2 years
All-cause hospitalizations
Time Frame: 2 years
The secondary endpoint of all-cause hospitalizations at 2-years will be compared between the HM3 Group and the Control Group within the Intention-to-treat (ITT) population. Additionally, the secondary endpoint of all-cause hospitalizations at 2-years will be descriptively compared between the Single Arm Registry and both the HM3 Group and Control Group of the Randomized Arm separately.
2 years
All adverse events (including all strokes) regardless of severity
Time Frame: 2 years
The secondary endpoint of all adverse events (including all strokes) regardless of severity at 2-years will be compared between the HM3 Group and the Control Group within the Intention-to-treat (ITT) population. Additionally, the secondary endpoint of all adverse events (including all strokes) regardless of severity at 2-years will be descriptively compared between the Single Arm Registry and both the HM3 Group and Control Group of the Randomized Arm separately.
2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival free of urgent LVAD or transplant
Time Frame: 5 years
This additional descriptive analysis at 5-years will be performed to evaluate the proportion of patients who are alive and free of device replacement or transplant in the HM3 Group compared to the Single Arm Registry (de novo implant or transplant)
5 years
Finkelstein-Schoenfeld Win Ratio
Time Frame: 5 years

The Finkelstein-Schoenfeld Win Ratio will be explored at 5 years as an additional analysis with the following hierarchy:

  1. Survival
  2. Days alive outside of the hospital
  3. Quality of Life assessed with the KCCQ (considered a tie if within 10 points)
  4. Functional Capacity (Six-minute walk distance)

The Finkelstein-Schoenfeld Win Ratio will be analyzed between the HM3 Group and the Control Group within the Intention-to-treat (ITT) population. Additionally, the Finkelstein-Schoenfeld Win Ratio will be descriptively analyzed between the Single Arm and both the HM3 Group and Control Group of the Randomized Arm separately.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Study Director: Kelly O'Connell, PhD, Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2024

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2032

Study Registration Dates

First Submitted

July 24, 2024

First Submitted That Met QC Criteria

July 24, 2024

First Posted (Actual)

July 29, 2024

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABT- CIP-10521

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

product manufactured in and exported from the U.S.

No

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