PROACTIVE-HF IDE Trial Heart Failure NYHA Class III (PROACTIVE-HF)

February 15, 2024 updated by: Endotronix, Inc.

A Prospective, Multi-Center, Open Label, Single Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in NYHA Class III Heart Failure Patients (PROACTIVE- HF Trial)

This is a prospective, open- label, single arm, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System in NYHA Class III Heart Failure Patients compared to a Performance Goal (PG).

Study Overview

Status

Active, not recruiting

Study Type

Interventional

Enrollment (Actual)

457

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 Locations

      • Aalst, Belgium
        • Cardiovascular Center OLV Aalst
      • Antwerp, Belgium
        • ZNA Middlheim
      • Genk, Belgium
        • Ziekenhuis- Oost Limburg
      • Ronse, Belgium
        • AZ Glorieux Ronse
      • Galway, Ireland
        • University Hospital Galway
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Ascension St Vincent's
      • Huntsville, Alabama, United States, 35801
        • Huntsville Hospital
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • Phoenix Cardiovascular Research Group/Insight
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University
      • Rancho Mirage, California, United States, 92270
        • Eisenhower Medical Center
      • San Diego, California, United States, 92037
        • UCSD
      • San Francisco, California, United States, 94143
        • UCSF Medical Center
      • San Francisco, California, United States, 94118
        • Kaiser San Francisco
      • Santa Clara, California, United States, 95051
        • Kaiser Santa Clara
    • Colorado
      • Littleton, Colorado, United States, 80120
        • South Denver Cardiology
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
    • Florida
      • Miami, Florida, United States, 33176
        • Baptist Health South Florida
      • Pensacola, Florida, United States, 32504
        • Ascension Sacred Heart
      • Tampa, Florida, United States, 33609
        • USF Health
      • Weston, Florida, United States, 33331
        • Cleveland Clinic
    • Georgia
      • Athens, Georgia, United States, 30600
        • Piedmont Athens
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Queens Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern
      • Chicago, Illinois, United States, 60637
        • U of Chicago
      • Palos Park, Illinois, United States, 60464
        • Heart Centers of Illinois
      • Peoria, Illinois, United States, 61107
        • OSF Healthcare
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Ascension St Vincent's
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Medical Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center (KUMC)
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
      • Baltimore, Maryland, United States, 21239
        • MedStar
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center (BIDMC)
      • Boston, Massachusetts, United States, 02215
        • Brigham and Women's Hospital (Mass General Brigham)
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute Foundation
      • Saint Cloud, Minnesota, United States, 56303
        • Centra Care Heart Center
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St. Lukes/ Mid-American Heart Institute
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • Ridgewood, New Jersey, United States, 07450
        • The Valley Hospital
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai
      • New York, New York, United States, 11794
        • NYU Langone Health
      • Queens, New York, United States, 11355
        • New York Presbyterian Queens
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Med Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health Science Portland
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Thomas Jefferson Abington
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Health
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Medicine
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • PRISMA Midlands - Palmetto
      • Greenville, South Carolina, United States, 29605
        • PRISMA Health- Upstate
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Sanford
    • Tennessee
      • Knoxville, Tennessee, United States, 37934
        • Tennova Healthcare (Turkey Creek Medical Center)
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt
    • Texas
      • Austin, Texas, United States, 78756
        • Austin Heart
      • Gonzales, Texas, United States, 78155
        • Craig Cardiovascular Center
      • Houston, Texas, United States, 77030
        • Houston Methodist
      • Houston, Texas, United States, 77030
        • Baylor/Texas Heart
      • Houston, Texas, United States, 77030
        • University of Texas/Hermann Memorial
      • Round Rock, Texas, United States, 78655
        • Baylor - Round Rock
      • San Antonio, Texas, United States, 78229
        • Methodist Healthcare System
      • Temple, Texas, United States, 76508
        • Baylor - Temple
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont
    • Virginia
      • Norfolk, Virginia, United States, 22191
        • Sentara Healthcare
      • Winchester, Virginia, United States, 22601
        • Valley Health System/Winchester Medical Center
    • Washington
      • Seattle, Washington, United States, 98196
        • University of Washington
      • Spokane, Washington, United States, 99204
        • Providence Health Care
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  1. Subject has given written informed consent
  2. Male or female, at least 18 years of age
  3. Diagnosis and treatment of HF (regardless of left ventricular ejection fraction (LVEF)) for ≥ 3 months and NYHA Class III HF at time of Screening
  4. 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, or current European Society of Cardiology (ESC) guidelines for HF treatment in Europe, with any intolerance documented.
  5. HF related hospitalization, HF treatment in a hospital day-care setting, or urgent outpatient clinic HF visit for IV diuretics within 12 month (last hospitalization should be 30 days before Screening/Enrollment) and/or N-terminal pro B-type Natriuretic Peptide (NT proBNP) at time of Screening/ Enrollment defined as:

    1. Subjects with LVEF ≤ 50%: NT-proBNP ≥ 1500 pg/mL.
    2. Subjects with LVEF > 50%: NT-proBNP ≥ 800 pg/mL . Thresholds for NT-proBNP (for both LVEF ≤ 50% and LVEF > 50%) will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 25 kg/m2
  6. Subjects should be on diuretic therapy
  7. Subjects who are physically able to hold the myCordella™ Patient Reader unit (approximate weight 1.3lb) against the ventral thoracic surface for up to 2 minutes per day while in a seated position, as well as dock and undock the myCordella™ Patient Reader
  8. Subjects with sufficient eyesight, hearing, and mental capacity to respond to the myCordella™ Patient Reader's audio/visual cues and operate the myCordella™ Patient Reader
  9. Subject has sufficient Cellular and/ or Wi- Fi Internet coverage at home
  10. Subject agrees to return to the treating Investigator for all scheduled follow up visits and can return to the hospital for follow up

Exclusion Criteria

  1. Intolerance to all neuro-hormonal antagonists (i.e., intolerance to ACE-I, ARB, ARNI, and beta-blockers) due to hypotension or renal dysfunction
  2. ACC/AHA Stage D refractory HF (including having received or currently receiving pharmacologic circulatory support with inotropes)
  3. Subjects with history of recurrent pulmonary embolism ( ≥2 episodes within 5 years prior to Screening Visit) and/or deep vein thrombosis (< 3 month prior to Screening Visit)
  4. Subjects who have had a major cardiovascular (CV) event (e.g. myocardial infarction, stroke) within 3 months of the Screening Visit
  5. Unrepaired severe valvular disease
  6. Subjects with significant congenital heart disease that has not been repaired and would prevent implantation of the Cordella PA sensor or mechanical/tissue right heart valve(s)
  7. Subjects with known coagulation disorders
  8. Subjects with a hypersensitivity or allergy to platelet aggregation inhibitors including aspirin, clopidogrel, prasugrel, and ticagrelor; or patients unable to take dual antiplatelet or anticoagulants for one-month post implant
  9. Known history of life threatening allergy to contrast dye
  10. Subjects whereby RHC is contraindicated
  11. Subjects with an active infection at the Sensor Implant Visit
  12. Subjects with a Glomerular Filtration Rate (GFR) <25 ml/min or who are on chronic renal dialysis
  13. Implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) for less than 90 days prior to screening visit
  14. Received or are likely to receive an advanced therapy (e.g. mechanical circulatory support or lung or heart transplant) in the next 12 months
  15. Subjects who are pregnant or breastfeeding
  16. Subjects who are unwilling or deemed by the Investigator to be unwilling to comply with the study protocol, or subjects with a history of non-compliance
  17. Severe illness, other than heart disease, which would limit survival to <1 year
  18. Subjects whose clinical condition, in the opinion of the Investigator, makes them an unsuitable candidate for the study
  19. Subjects enrolled in another investigational trial with an active treatment arm
  20. Subject who is in custody by order of an authority or a court of law

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: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Treatment Arm
Pulmonary Artery Pressure Guided Heart Failure Management (PAPGHFM) and Guideline Directed Medical Therapy (GDMT) considering daily Pulmonary Artery Pressure (PAP) measurements and vital signs collected by Cordella Heart Failure System (CHFS).

The Cordella PA Sensor System (CorPASS) is intended to measure, record, and transmit pulmonary artery pressure (PAP) data from NYHA Class III heart failure patients at home to clinicians for assessment and patient-centered heart failure management and comprises of seven subsystems that operate together to take daily Pulmonary Artery Pressure (PAP) readings at a patient's home and transmit the results to a care provider for evaluation.

  1. Cordella Sensor
  2. Cordella Delivery System
  3. myCordella Patient Reader
  4. Reader Dock
  5. Cordella Calibration Equipment (CalEQ)
  6. myCordella Hub
  7. Cordella Data Analysis Platform (CDAP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy 6 month incidence of HF related Hospitalizations (HFH) or all-cause mortality
Time Frame: 6 months
6 month incidence of HF related Hospitalizations (HFH) or all- cause mortality compared to a Performance Goal
6 months
Safety: Freedom from device/system related complication
Time Frame: 6 months
Freedom from device/system related complication at 6 months
6 months
Safety: Freedom from pressure sensor failure
Time Frame: 6 months
Freedom from pressure sensor failure at 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HF Hospitalizations
Time Frame: 6 months and 12 months
Number of HF Hospitalizations at 6 and 12 months post-implant compared to the number of HF Hospitalizations in the 6 and 12 months prior to implant
6 months and 12 months
HF Hospitalizations or Emergency Department/Hospital Outpatient IV diuretic visits.
Time Frame: 6 and 12 months
Comparison of the number of HF Hospitalizations, Emergency Department/ Hospital Outpatient IV diuretic visits of Cohort #1 and Cohort #2 at 6 and 12 months post implant at 6 months, added together with equal weighting into a total number of events
6 and 12 months
Mortality
Time Frame: 3 years
Cardiac and all-cause mortality
3 years
IV diuretic visits
Time Frame: 3 years
Intravenous (IV) diuretic visits
3 years
Pulmonary Artery Pressure (PAP)
Time Frame: 6 and 12 months
Change in PAP: a. From Baseline through 6 and 12 months in subjects with a baseline mPAP i. above target range ii. within or below target range iii. Overall b. Before and after 6-Minute Walk Test
6 and 12 months
Device success
Time Frame: 3 years
Percentage of device success as documented by ability of the System to successfully transmit PAP data transmit PAP data
3 years
KCCQ
Time Frame: 3 years
The Quality of Life KCCQ questionnaire is a measure of health-related quality of life. It is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life related to Heart Failure. Out of 23-items, 10 scores will be calculated: Physical Limitation, Symptom Stability, Symptom Frequency, Symptom Burden, Total Symptom Score, Self-Efficacy, Quality of Life, Social Limitation, Overall Summary Score, Clinical Summary Score .Presentation will be done by means of descriptive statistics including the absolute value and change from baseline by visit.
3 years
NYHA
Time Frame: 3 years
Subjects complete a six (6) minute walk test at the study visits described in the study protocol. Total distance walked (meters) will be collected and analyzed by means of descriptive statistics including the absolute value and change from baseline by visit
3 years
NYHA and 6-Minute Walk Test
Time Frame: 3 years
Functional status improvement, as measured by NYHA and 6-Minute Walk Test
3 years
Serious adverse events
Time Frame: 3 years
Frequency of serious adverse events throughout the study
3 years
Incidence of HF Hospitalizations or all-cause mortality
Time Frame: 12 months
Incidence of HF Hospitalizations or all-cause mortality at 12 months
12 months
N-terminal pro B-type Natriuretic Peptide (NT-proBNP
Time Frame: 6 and 12 months
Change of N-terminal pro B-type Natriuretic Peptide (NT-proBNP) from Baseline through 6 and 12 months
6 and 12 months
Days Alive and Out of Hospital (DAOH)
Time Frame: 3 years
Days Alive and Out of Hospital (DAOH)
3 years
Heart failure related Medication changes
Time Frame: 3 years
Heart failure related Medication changes
3 years
HF Hospitalization or all-cause mortality
Time Frame: 12 months
Incidence of HF Hospitalizations or all-cause mortality at 12 months
12 months
HF Hospitalization, Emergency Department/Hospital Outpatient IV diuretic visits, all-cause mortality
Time Frame: 6 months

Combined outcome of:

  1. First and recurrent Heart Failure Hospitalizations
  2. Emergency Department / Hospital Outpatient IV diuretic visits all-cause mortality at 6 months, added together with equal weighting into a total number of events.
6 months
HF Hospitalization, Emergency Department/Hospital Outpatient IV diuretic visits
Time Frame: 6 and 12 months
HF Hospitalization, Emergency Department/Hospital Outpatient IV diuretic visits at 6 and 12 months
6 and 12 months
Implant procedure and procedure related adverse events and serious adverse events
Time Frame: 3 years
Frequency of implant procedure and procedure related adverse events and serious adverse events
3 years

Collaborators and Investigators

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

Investigators

  • Study Director: Andrea Sauerland, Endotronix, Inc.

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)

January 10, 2020

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

August 30, 2019

First Submitted That Met QC Criteria

September 11, 2019

First Posted (Actual)

September 13, 2019

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETX-HFS-PA-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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