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NCT05934487NARecruiting

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

Endotronix, Inc.

Start Date

11/29/2023

Completion Date

9/1/2033

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

Age Range: 18 years to No maximum

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 4\. 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. 1. 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 Screening/Enrollment 2. 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 Screening/Enrollment 5. NYHA II Cohort- HF related hospitalization within 6 months (last hospitalization should be 30 days before Screening /Enrollment) 5. NYHA III Cohort -HF related hospitalization within 12 month (last hospitalization should be 30 days before Screening/Enrollment) 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: 1. 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)) 2. 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) 3. 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) 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 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 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 14. 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 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 \<2 years 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

Interventions

DEVICE

Cordella™ Pulmonary Artery Sensor System

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Conditions

Heart Failure NYHA Class IIHeart Failure NYHA Class IIIHeart Failure

Locations

St. Joseph's Hospital and Medical Center

Phoenix, Arizona 85013

United States

USC

Los Angeles, California 90033

United States

UCSF Medical Center

San Francisco, California 94143

United States

Baptist Health South Florida

Miami, Florida 33176

United States

Ascension Sacred Heart

Pensacola, Florida 32504

United States

Piedmont

Atlanta, Georgia 30309

United States

Advocate Health System

Downers Grove, Illinois 60515

United States

Heart Care Centers of Illinois (HCCI)

Palos Park, Illinois 60464

United States

Ascension St. Vincent's

Indianapolis, Indiana 46260

United States

University of Kansas Medical Center (KUMC)

Kansas City, Kansas 66160

United States

MedStar

Baltimore, Maryland 21239

United States

Tufts Medical Center

Boston, Massachusetts 02111

United States

Boston Medical Center Corporation

Boston, Massachusetts 02118

United States

Ascension Providence Hospital Cardiology - Heart Cardiology

Howell, Michigan 48843

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

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

Stony Brook University Med Center

Stony Brook, New York 11794

United States

UNC Medical Center

Durham, North Carolina 27703

United States

Duke University

Durham, North Carolina 27710

United States

The Christ Hospital- Cincinnati

Cincinnati, Ohio 45219

United States

University of Cincinnati

Cincinnati, Ohio 45267

United States

University Hospital (Cleveland)

Cleveland, Ohio 44106

United States

Providence St. Vincent's - Portland

Portland, Oregon 97225

United States

Oregon Health Science Portland

Portland, Oregon 97239

United States

Penn State Health

Hershey, Pennsylvania 17033

United States

UPMC

Pittsburgh, Pennsylvania 15213

United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina 29425

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

Dallas, Texas 75246

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

Providence Everett

Everett, Washington 98201

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

AZORG Aalst

Aalst, 9300

Belgium

UZ Brussel

Brussels,

Belgium

University Hospital Galway

Galway,

Ireland