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First received: June 26, 2023

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

Study Status: Completed

Recruit Status: RECRUITING

Condition: Heart Failure NYHA Class II

Study Type: INTERVENTIONAL


Official Title: A Prospective, Multi-Center, Open Label, Randomized Control Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class

Brief 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:Randomized Arm - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class II HF patients.Treatment Arm (Cohort 1)Active Control Arm (Cohort 2)Crossover Arm (Cohort 3)Single Arm - To demonstrate safety and efficacy of the Cordella PA…

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