PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III
Sponsored by Endotronix, Inc.
About this study
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.
Enrolling at this location
Medical University of South Carolina (MUSC)
Charleston, South Carolina
I'm interestedThis study also enrolls at 49 other locations. See all.
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Trial data sourced from ClinicalTrials.gov.