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

Recruiting now · Not applicable

Conditions studied: Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure

In brief

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.

Key facts

Study ID

NCT05934487

Run by

Endotronix, Inc.

People needed

1750

Starts

2023-11-29

Expected to finish

2033-09-01

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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

Where it is running

• Medical City Healthcare Dallas — Dallas, Texas, United States (enrolling)
• USC — Los Angeles, California, United States (enrolling)
• UCSF Medical Center — San Francisco, California, United States (enrolling)
• Baptist Health South Florida — Miami, Florida, United States (enrolling)
• Ascension Sacred Heart — Pensacola, Florida, United States (enrolling)
• Piedmont — Atlanta, Georgia, United States (enrolling)
• Advocate Health System — Downers Grove, Illinois, United States (enrolling)
• Heart Care Centers of Illinois (HCCI) — Palos Park, Illinois, United States (enrolling)
• Ascension St. Vincent's — Indianapolis, Indiana, United States (enrolling)
• University of Kansas Medical Center (KUMC) — Kansas City, Kansas, United States (enrolling)
• MedStar — Baltimore, Maryland, United States (enrolling)
• Tufts Medical Center — Boston, Massachusetts, United States (enrolling)
• Providence Everett — Everett, Washington, United States (enrolling)
• West Virginia University — Morgantown, West Virginia, United States (enrolling)
• University of Wisconsin — Madison, Wisconsin, United States (enrolling)
• Advocate Aurora St. Luke's — Milwaukee, Wisconsin, United States (enrolling)
• Ascension Providence Hospital Cardiology - Heart Cardiology — Howell, Michigan, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• Centra Care Heart Center — Saint Cloud, Minnesota, United States (enrolling)
• St. Lukes/ Mid-American Heart Institute — Kansas City, Missouri, United States (enrolling)
• Mount Sinai West — New York, New York, United States (enrolling)
• Mount Sinai — New York, New York, United States (enrolling)
• Lenox Hill/ Northwell Health — New York, New York, United States (enrolling)
• Stony Brook University Med Center — Stony Brook, New York, United States (enrolling)
• UNC Medical Center — Durham, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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