PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III

Last updated: February 5, 2025
Sponsor: Endotronix, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Hyponatremia

Chest Pain

Treatment

Cordella™ Pulmonary Artery Sensor System

Clinical Study ID

NCT05934487
ETX-HFS-PA-04
  • Ages > 18
  • All Genders

Study Summary

This is a prospective, multi-center, open label, randomized control clinical trial evaluating the safety and efficacy of the Cordella™ Pulmonary Artery Sensor System in NYHA Class II-III Heart Failure Patients (PROACTIVE-HF-2 Trial).

The study contains of 5 arms:

NYHA II Cohort - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class II HF patients, where patients have daily access to PAP data.

  • Treatment Arm (Group 1)

  • Active Control Arm (Group 2)

  • Crossover Arm (Group 3)

NYHA III Cohort - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class III HF patients, where patients have daily access to PAP data, including a randomized sub-study to evaluate a clinician-directed patient self-management strategy.

Eligibility Criteria

Inclusion

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 LVEF) for ≥ 3 months and NYHA Class II HF (NYHA II Cohort) or NYHA III (NYHA III Cohort) at time of Screening

  1. Subjects should be receiving appropriate medical therapy for heart failure accordingto current AHA/ACC guidelines as standard-of-care for HF therapy in the UnitedStates, or current ESC guidelines for HF treatment in Europe for at least 30 daysprior to the Screening/Enrollment visit. Stable is defined as no more than a 100%increase or 50% decrease in dose. These criteria may be waived if a subject isintolerant of ACE-I, ARB, ARNI), MRA, beta-blockers, or SGLT2i, subject is unable toafford these agents, subject has contraindications to these agents, or these agentsare not indicated under the Guidelines. Such intolerance, lack of affordability,contraindications, or lack of indications must be documented.

  2. HFrEF (EF < 50%): Subject has been on stable medications maximized to the subject'stolerance of ACE-I or ARB or ARNI, MRA, beta-blockers, and SGLT2i as determined bythe study investigator for at least 30 days prior to Screening/Enrollment

  3. HFpEF (EF ≥ 50%): Subject has been on stable medication maximized to the subject'stolerance of SGLT2i as determined by the study investigator for at least 30 daysprior to Screening/Enrollment 5. NYHA II Cohort- HF related hospitalization within 6months (last hospitalization should be 30 days before Screening /Enrollment) 5. NYHAIII Cohort -HF related hospitalization within 12 month (last hospitalization shouldbe 30 days before Screening/Enrollment)

  4. Subjects should be on diuretic therapy (≥40 mg] furosemide or equivalent) for ≥ 1 month at time of Screening

  5. Subjects who are physically able to hold the myCordella™ Patient Reader unit (approximate weight 1.3lb) against the ventral thoracic surface for up to 2minutes per day while in a seated position, as well as dock and undock themyCordella™ Patient Reader

  6. Subjects with sufficient eyesight, hearing, and mental capacity to respond tothe myCordella™ Patient Reader's audio/visual cues and operate the myCordella™Patient Reader

  7. Subject has sufficient Cellular and/ or Wi- Fi Internet coverage at home

  8. Subject agrees to return to the treating Investigator for all scheduled followup visits and can return to the hospital for follow up

Exclusion

Exclusion Criteria:

  1. ACC/AHA Stage D refractory HF (including a known history of >24 hours of IVinotropic therapy to support circulation within the past 6 months (other thanrelation to a procedure))

  2. Subjects with history of recurrent pulmonary embolism (≥2 episodes within 5years prior to Screening Visit) and/or deep vein thrombosis in the femoral orIJ vein used for access (< 3 month prior to Screening Visit)

  3. Subjects with a resting systolic blood pressure <90 mmHg and/ or severepre-capillary pulmonary hypertension with a pulmonary artery systolic pressureof ≥70 mm/Hg with pulmonary capillary wedge pressure ≤ 15 mmHg at the CordellaPA Sensor Implant RHC (V2)

  4. Subjects who have had a major cardiovascular (CV) event (e.g., myocardialinfarction, stroke) within 3 months of the Screening Visit

  5. Unrepaired severe valvular disease

  6. Subjects with significant congenital heart disease that has not been repairedand would prevent implantation of the Cordella PA Sensor or mechanical/tissueright heart valve(s)

  7. Subjects with known coagulation disorders

  8. Subjects with a hypersensitivity or allergy to platelet aggregation inhibitorsincluding aspirin, clopidogrel, prasugrel, and ticagrelor; or patients unableto 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 Cordella Sensor Implant Visit

  12. Subjects with a GFR <20 ml/min or who are on chronic renal dialysis

  13. Implanted with Cardiac Resynchronization Therapy-Pacemaker (CRT-P) or CardiacResynchronization Therapy-Defibrillator (CRT-D), or having undergonemitral/tricuspid valve repair/replacement within 90 days or catheter ablationfor atrial fibrillation within 30 days prior to screening visit

  14. Received or are likely to receive an advanced therapy (e.g., durable mechanicalcirculatory support or lung or heart transplant) in the next 24 months

  15. Subjects who are pregnant or breastfeeding

  16. Subjects who are unwilling or deemed by the Investigator to be unwilling tocomply with the study protocol, or subjects with a history of non-compliance

  17. Severe illness, other than heart disease, which would limit survival to <2years

  18. Subjects whose clinical condition, in the opinion of the Investigator, makesthem 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 Design

Total Participants: 1750
Treatment Group(s): 1
Primary Treatment: Cordella™ Pulmonary Artery Sensor System
Phase:
Study Start date:
November 29, 2023
Estimated Completion Date:
September 30, 2033

Connect with a study center

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona 85013
    United States

    Active - Recruiting

  • Loma Linda University

    Loma Linda, California 92354
    United States

    Site Not Available

  • USC

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • San Diego Cardiac Care

    San Diego, California 92123
    United States

    Site Not Available

  • UCSF Medical Center

    San Francisco, California 94143
    United States

    Active - Recruiting

  • South Denver Cardiology

    Denver, Colorado 80210
    United States

    Site Not Available

  • Baptist Health South Florida

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Ascension Sacred Heart

    Pensacola, Florida 32504
    United States

    Active - Recruiting

  • Cleveland Clinic

    Weston, Florida 33331
    United States

    Site Not Available

  • Piedmont

    Atlanta, Georgia 30309
    United States

    Active - Recruiting

  • Northwestern

    Chicago, Illinois 60611
    United States

    Site Not Available

  • U of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Advocate Health System

    Downers Grove, Illinois 60515
    United States

    Site Not Available

  • Heart Care Centers of Illinois (HCCI)

    Palos Park, Illinois 60464
    United States

    Active - Recruiting

  • OSF Healthcare

    Peoria, Illinois 61107
    United States

    Site Not Available

  • Ascension St. Vincent's

    Indianapolis, Indiana 46260
    United States

    Active - Recruiting

  • University of Iowa Medical Center

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Kansas Medical Center (KUMC)

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • St. Elizabeth's Healthcare

    Edgewood, Kentucky 41017
    United States

    Site Not Available

  • University Of Louisville

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • MedStar

    Baltimore, Maryland 21239
    United States

    Active - Recruiting

  • University of Maryland

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center (BIDMC)

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Active - Recruiting

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Ascension Providence Hospital Cardiology - Heart Cardiology

    Howell, Michigan 48843
    United States

    Active - Recruiting

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

  • Centra Care Heart Center

    Saint Cloud, Minnesota 56303
    United States

    Site Not Available

  • Centra Care Heart Center

    St. Cloud, Minnesota 56303
    United States

    Active - Recruiting

  • St. Lukes/ Mid-American Heart Institute

    Kansas City, Missouri 64111
    United States

    Active - Recruiting

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • University of Nebraska

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • Lenox Hill/ Northwell Health

    New York, New York 10075
    United States

    Active - Recruiting

  • Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • Mount Sinai West

    New York, New York 10019
    United States

    Active - Recruiting

  • NYU Langone Health

    New York, New York 11794
    United States

    Site Not Available

  • Stony Brook University Med Center

    Stony Brook, New York 11794
    United States

    Active - Recruiting

  • Duke University

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • The Christ Hospital- Cincinnati

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • University of Cincinnati

    Cincinnati, Ohio 45267
    United States

    Active - Recruiting

  • University Hospital (Cleveland)

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Oregon Health Science Portland

    Portland, Oregon 97239
    United States

    Site Not Available

  • Providence St. Vincent's - Portland

    Portland, Oregon 97225
    United States

    Active - Recruiting

  • TJ Abington

    Abington, Pennsylvania 190001
    United States

    Site Not Available

  • Penn State Health

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Penn Medicine (UPENN)

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • UPMC

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • PRISMA Midlands - Palmetto

    Columbia, South Carolina 29203
    United States

    Site Not Available

  • PRISMA Health- Upstate

    Greenville, South Carolina 29605
    United States

    Site Not Available

  • Sanford

    Sioux Falls, South Dakota 57105
    United States

    Active - Recruiting

  • Vanderbilt

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Austin Heart

    Austin, Texas 78756
    United States

    Site Not Available

  • Medical City Healthcare Dallas

    Dallas, Texas 75240
    United States

    Active - Recruiting

  • Baylor Scott & White -Dallas

    Fort Worth, Texas 76110
    United States

    Active - Recruiting

  • Baylor/Texas Heart

    Houston, Texas 77030
    United States

    Site Not Available

  • Methodist San Antonio

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Baylor - Temple

    Temple, Texas 76508
    United States

    Active - Recruiting

  • University of Vermont

    Burlington, Vermont 05401
    United States

    Site Not Available

  • Sentara Healthcare

    Norfolk, Virginia 22191
    United States

    Site Not Available

  • Providence Everett

    Everett, Washington 98201
    United States

    Active - Recruiting

  • Providence Health Care

    Spokane, Washington 99204
    United States

    Site Not Available

  • West Virginia University

    Morgantown, West Virginia 26506
    United States

    Site Not Available

  • University of Wisconsin

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

  • Advocate Aurora St. Luke's

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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