Heart Failure Clinical Trial

PROACTIVE-HF IDE Trial Heart Failure NYHA Class III

Summary

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).

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 left ventricular ejection fraction (LVEF)) for ≥ 3 months and NYHA Class III HF at time of Screening
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.

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:

Subjects with LVEF ≤ 50%: NT-proBNP ≥ 1500 pg/mL.
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
Subjects should be on diuretic therapy
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
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
Subject has sufficient Cellular and/ or Wi- Fi Internet coverage at home
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

Intolerance to all neuro-hormonal antagonists (i.e., intolerance to ACE-I, ARB, ARNI, and beta-blockers) due to hypotension or renal dysfunction
ACC/AHA Stage D refractory HF (including having received or currently receiving pharmacologic circulatory support with inotropes)
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)
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 Sensor Implant Visit
Subjects with a Glomerular Filtration Rate (GFR) <25 ml/min or who are on chronic renal dialysis
Implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) for less than 90 days prior to screening visit
Received or are likely to receive an advanced therapy (e.g. mechanical circulatory support or lung or heart transplant) in the next 12 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 <1 year
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:

457

Study ID:

NCT04089059

Recruitment Status:

Active, not recruiting

Sponsor:

Endotronix, Inc.

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There are 66 Locations for this study

See Locations Near You

Ascension St Vincent's
Birmingham Alabama, 35235, United States
Huntsville Hospital
Huntsville Alabama, 35801, United States
Phoenix Cardiovascular Research Group/Insight
Phoenix Arizona, 85018, United States
Loma Linda University
Loma Linda California, 92354, United States
Eisenhower Medical Center
Rancho Mirage California, 92270, United States
UCSD
San Diego California, 92037, United States
Kaiser San Francisco
San Francisco California, 94118, United States
UCSF Medical Center
San Francisco California, 94143, United States
Kaiser Santa Clara
Santa Clara California, 95051, United States
South Denver Cardiology
Littleton Colorado, 80120, United States
Hartford Hospital
Hartford Connecticut, 06102, United States
Baptist Health South Florida
Miami Florida, 33176, United States
Ascension Sacred Heart
Pensacola Florida, 32504, United States
USF Health
Tampa Florida, 33609, United States
Cleveland Clinic
Weston Florida, 33331, United States
Piedmont Athens
Athens Georgia, 30600, United States
Queens Medical Center
Honolulu Hawaii, 96813, United States
Northwestern
Chicago Illinois, 60611, United States
U of Chicago
Chicago Illinois, 60637, United States
Heart Centers of Illinois
Palos Park Illinois, 60464, United States
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
University Of Louisville
Louisville Kentucky, 40202, United States
Ochsner Medical Center
New Orleans Louisiana, 70121, 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
Brigham and Women's Hospital (Mass General Brigham)
Boston Massachusetts, 02215, United States
Henry Ford Hospital
Detroit Michigan, 48202, 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
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
The Valley Hospital
Ridgewood New Jersey, 07450, United States
Mount Sinai
New York New York, 10029, United States
NYU Langone Health
New York New York, 11794, United States
New York Presbyterian Queens
Queens New York, 11355, United States
Stony Brook University Med Center
Stony Brook New York, 11794, United States
University of Cincinnati
Cincinnati Ohio, 45267, United States
Ohio State University
Columbus Ohio, 43210, United States
Oregon Health Science Portland
Portland Oregon, 97239, United States
Thomas Jefferson Abington
Abington Pennsylvania, 19001, United States
Penn State Health
Hershey Pennsylvania, 17033, United States
Penn Medicine
Philadelphia Pennsylvania, 19104, United States
Thomas Jefferson
Philadelphia Pennsylvania, 19107, 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
Tennova Healthcare (Turkey Creek Medical Center)
Knoxville Tennessee, 37934, United States
Vanderbilt
Nashville Tennessee, 37232, United States
Austin Heart
Austin Texas, 78756, United States
Craig Cardiovascular Center
Gonzales Texas, 78155, United States
Baylor/Texas Heart
Houston Texas, 77030, United States
Houston Methodist
Houston Texas, 77030, United States
University of Texas/Hermann Memorial
Houston Texas, 77030, United States
Baylor - Round Rock
Round Rock Texas, 78655, United States
Methodist Healthcare System
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
Valley Health System/Winchester Medical Center
Winchester Virginia, 22601, United States
University of Washington
Seattle Washington, 98196, 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
Cardiovascular Center OLV Aalst
Aalst , , Belgium
ZNA Middlheim
Antwerp , , Belgium
Ziekenhuis- Oost Limburg
Genk , , Belgium
AZ Glorieux Ronse
Ronse , , Belgium
University Hospital Galway
Galway , , Ireland

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

457

Study ID:

NCT04089059

Recruitment Status:

Active, not recruiting

Sponsor:


Endotronix, Inc.

How clear is this clinincal trial information?

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