PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III (NCT05934487) | Clinical Trial Compass
RecruitingNot Applicable
PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III
United States1,750 participantsStarted 2023-11-29
Plain-language summary
This is a prospective, multi-center, open label, randomized control clinical trial evaluating the safety and efficacy of the Cordellaâ„¢ 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. 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)
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)
What they're measuring
1
Efficacy- NYHA II Cohort - A composite of first HF event or death from Cardiovascular Death up to 24 months.
Timeframe: 24 months
2
Efficacy- NYHA III Cohort (Phase I) - a composite of HF events or death from cardiovascular disease at 6 months
Timeframe: 12 months
3
Safety- Randomized Arm- Freedom from device/system related complication
Timeframe: 24 months
4
Safety- Randomized Arm-Freedom from pressure sensor failure
Timeframe: 24 months
5
Safety- Single Arm-Freedom from device/system related complication
Timeframe: 12 months
6
Safety- Single Arm- Freedom from pressure sensor failure
Timeframe: 12 months
7
Efficacy- NYHA III Cohort (Phase II) - A test of non-inferiority at 12 months of the percentage of patients at or below trend seated mPAP of 25 mmHg in (i) Clinician-Directed Patient Self-Management vs. (ii) Clinician Management Arm
✕. 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