Randomized Arm: This is a prospective, open label, randomized, controlled, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System in patients enrolled with NYHA Class II Heart Failure. Single Arm:This is a prospective, open label, single arm, controlled, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System linked with a clinician-directed patient self-management strategy in patients enrolled with NYHA Class III Heart Failure comparedto a Performance Goal (PG).
ROACTIVE-HF II
Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor
System in New York Heart Association (NYHA) Class II-III Heart Failure Patients
(PROACTIVE-HF-2 Trial)
System in New York Heart Association (NYHA) Class II-III Heart Failure Patients
(PROACTIVE-HF-2 Trial)
Heart failure
All genders
18+
Recruiting now
Overview
Principal Investigator: Michael Kiernan, MD
Contact Us
Easton Cummins/Gaurav Das
Study details
Inclusion Criteria
- 1 . 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
- 2. 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 randomization 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.
a. 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
b. 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 - 3. Subjects should be on diuretic therapy ([≥40 mg] furosemide or equivalent) for ≥ 1 month at time of Screening
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 on screening baseline echocardiogram
Study Requirements
We expect that you will be in this research study for approximately 5 years, and you will need to come to the study center at least 10 times over this period.