Heart Failure Clinical Trial

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

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:

Randomized Arm - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class II HF patients.

Treatment Arm (Cohort 1)
Active Control Arm (Cohort 2)
Crossover Arm (Cohort 3)

Single Arm - To demonstrate safety and efficacy of the Cordella PA Sensor System linked with a clinician-directed patient self-management strategy in NYHA Class III HF patients.

Clinician-Directed Patient Self-Management Arm (Cohort 4)
Clinician Management Arm (Cohort 5)

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria

Subject has given written informed consent
Male or female, at least 18 years of age
Diagnosis and treatment of HF (regardless of LVEF) for ≥ 3 months and NYHA Class II HF (Randomized Arm) or NYHA III (Single Arm) at time of Screening

Subjects should be receiving appropriate medical therapy for heart failure according to current AHA/ACC guidelines as standard-of-care for HF therapy in the United States, or current ESC guidelines for HF treatment in Europe for at least 30 days prior 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 is intolerant of ACE-I, ARB, ARNI), MRA, beta-blockers, or SGLT2i, subject is unable to afford these agents, subject has contraindications to these agents, or these agents are not indicated under the Guidelines. Such intolerance, lack of affordability, contraindications, or lack of indications must be documented.

HFrEF (EF < 50%): Subject has been on stable medications maximized to the subject's tolerance of ACE-I or ARB or ARNI, MRA, beta-blockers, and SGLT2i as determined by the study investigator for at least 30 days prior to randomization
HFpEF (EF ≥ 50%): Subject has been on stable medication maximized to the subject's tolerance of SGLT2i as determined by the study investigator for at least 30 days prior to randomization
Randomized Arm- HF related hospitalization or urgent HF visit within 6 months (last hospitalization should be 30 days before Screening /Enrollment)

5. Single Arm-HF related hospitalization or urgent HF visit 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:

Subjects with LVEF ≤ 50%: NT-proBNP ≥ 1000 pg/mL.

Subjects with LVEF > 50%: NT-proBNP ≥ 700 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 (≥40 mg] furosemide or equivalent) for ≥ 1 month at time of Screening

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:

ACC/AHA Stage D refractory HF (including a known history of >24 hours of IV inotropic therapy to support circulation within the past 6 months (other than relation to a procedure))
Subjects with history of recurrent pulmonary embolism (≥2 episodes within 5 years prior to Screening Visit) and/or deep vein thrombosis in the femoral or IJ vein used for access (< 3 month prior to Screening Visit)
Subjects with a resting systolic blood pressure <90 mmHg and/ or severe pre-capillary pulmonary hypertension with a pulmonary artery systolic pressure of ≥70 mm/Hg with pulmonary capillary wedge pressure ≤ 15 mmHg at the Cordella PA Sensor Implant RHC (V2)
Subjects who have had a major cardiovascular (CV) event (e.g., myocardial infarction, stroke) within 3 months of the Screening Visit
Unrepaired severe valvular disease
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)
Subjects with known coagulation disorders
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
Known history of life-threatening allergy to contrast dye.
Subjects whereby RHC is contraindicated
Subjects with an active infection at the Cordella Sensor Implant Visit
Subjects with a GFR <20 ml/min or who are on chronic renal dialysis
Implanted with Cardiac Resynchronization Therapy-Pacemaker (CRT-P) or Cardiac Resynchronization Therapy-Defibrillator (CRT-D), or having undergone mitral/tricuspid valve repair/replacement within 90 days or catheter ablation for atrial fibrillation within 30 days prior to screening visit
Received or are likely to receive an advanced therapy (e.g., durable mechanical circulatory support or lung or heart transplant) in the next 24 months
Subjects who are pregnant or breastfeeding
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
Severe illness, other than heart disease, which would limit survival to <2 years
Subjects whose clinical condition, in the opinion of the Investigator, makes them an unsuitable candidate for the study
Subjects enrolled in another investigational trial with an active Treatment Arm
Subject who is in custody by order of an authority or a court of law

Study is for people with:

Heart Failure

Estimated Enrollment:

1650

Study ID:

NCT05934487

Recruitment Status:

Recruiting

Sponsor:

Endotronix, Inc.

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There are 62 Locations for this study

See Locations Near You

St. Joseph's Hospital and Medical Center
Phoenix Arizona, 85013, United States
Loma Linda University
Loma Linda California, 92354, United States
USC
Los Angeles California, 90033, United States
San Diego Cardiac Care
San Diego California, 92123, United States
UCSF Medical Center
San Francisco California, 94143, United States
South Denver Cardiology
Denver Colorado, 80210, United States
Baptist Health South Florida
Miami Florida, 33176, United States
Ascension Sacred Heart
Pensacola Florida, 32504, United States More Info
Ashley Corlies
Contact
Rohit Amin
Principal Investigator
Cleveland Clinic
Weston Florida, 33331, United States
Piedmont
Atlanta Georgia, 30309, United States
Northwestern
Chicago Illinois, 60611, United States
U of Chicago
Chicago Illinois, 60637, United States
Advocate Health System
Downers Grove Illinois, 60515, United States
Heart Care Centers of Illinois (HCCI)
Palos Park Illinois, 60464, United States More Info
Courtney Montgomery
Contact
Gregory Macaluso
Principal Investigator
OSF Healthcare
Peoria Illinois, 61107, United States
Ascension St. Vincent's
Indianapolis Indiana, 46260, United States
University of Iowa Medical Center
Iowa City Iowa, 52242, United States
University of Kansas Medical Center (KUMC)
Kansas City Kansas, 66160, United States
St. Elizabeth's Healthcare
Edgewood Kentucky, 41017, United States
University Of Louisville
Louisville Kentucky, 40202, United States
University of Maryland
Baltimore Maryland, 21201, United States
MedStar
Baltimore Maryland, 21239, United States
Tufts Medical Center
Boston Massachusetts, 02111, United States
Beth Israel Deaconess Medical Center (BIDMC)
Boston Massachusetts, 02215, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Ascension Providence Hospital Cardiology - Heart Cardiology
Howell Michigan, 48843, United States
Minneapolis Heart Institute Foundation
Minneapolis Minnesota, 55407, United States
University of Minnesota
Minneapolis Minnesota, 55455, United States
Centra Care Heart Center
Saint Cloud Minnesota, 56303, United States
St. Lukes/ Mid-American Heart Institute
Kansas City Missouri, 64111, United States
Washington University
Saint Louis Missouri, 63110, United States
University of Nebraska
Omaha Nebraska, 68198, United States
Mount Sinai West
New York New York, 10019, United States
Mount Sinai
New York New York, 10029, United States
Lenox Hill/ Northwell Health
New York New York, 10075, United States
NYU Langone Health
New York New York, 11794, United States
Stony Brook University Med Center
Stony Brook New York, 11794, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
The Christ Hospital- Cincinnati
Cincinnati Ohio, 45219, United States
University of Cincinnati
Cincinnati Ohio, 45267, United States
Providence St. Vincent's - Portland
Portland Oregon, 97225, United States
Oregon Health Science Portland
Portland Oregon, 97239, United States
TJ Abington
Abington Pennsylvania, 19000, United States
Penn State Health
Hershey Pennsylvania, 17033, United States
Penn Medicine (UPENN)
Philadelphia Pennsylvania, 19104, United States
UPMC
Pittsburgh Pennsylvania, 15213, United States
PRISMA Midlands - Palmetto
Columbia South Carolina, 29203, United States
PRISMA Health- Upstate
Greenville South Carolina, 29605, United States
Sanford
Sioux Falls South Dakota, 57105, United States
Vanderbilt
Nashville Tennessee, 37232, United States
Austin Heart
Austin Texas, 78756, United States
Medical City Healthcare Dallas
Dallas Texas, 75240, United States
Baylor Scott & White -Dallas
Fort Worth Texas, 76110, United States
Baylor/Texas Heart
Houston Texas, 77030, United States
Methodist San Antonio
San Antonio Texas, 78229, United States
Baylor - Temple
Temple Texas, 76508, United States
University of Vermont
Burlington Vermont, 05401, United States
Sentara Healthcare
Norfolk Virginia, 22191, United States
Providence Everett
Everett Washington, 98201, United States
Providence Health Care
Spokane Washington, 99204, United States
West Virginia University
Morgantown West Virginia, 26506, United States
University of Wisconsin
Madison Wisconsin, 53792, United States
Advocate Aurora St. Luke's
Milwaukee Wisconsin, 53215, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

1650

Study ID:

NCT05934487

Recruitment Status:

Recruiting

Sponsor:


Endotronix, Inc.

How clear is this clinincal trial information?

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