Condition: Heart Failure NYHA Class II · Heart Failure NYHA Class III · Heart Failure · Sponsor: Endotronix, Inc.
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.
This description comes directly from the study's public registry record.
Sarah Walton · (630) 473-3200 · sarah_walton@edwards.com
Always discuss trial participation with your own doctor first.
| St. Joseph's Hospital and Medical Center | Phoenix, Arizona, United States | Recruiting |
| USC | Los Angeles, California, United States | Recruiting |
| UCSF Medical Center | San Francisco, California, United States | Recruiting |
| Baptist Health South Florida | Miami, Florida, United States | Recruiting |
| Ascension Sacred Heart | Pensacola, Florida, United States | Recruiting |
| Piedmont | Atlanta, Georgia, United States | Recruiting |
| Advocate Health System | Downers Grove, Illinois, United States | Recruiting |
| Heart Care Centers of Illinois (HCCI) | Palos Park, Illinois, United States | Recruiting |
| Ascension St. Vincent's | Indianapolis, Indiana, United States | Recruiting |
| University of Kansas Medical Center (KUMC) | Kansas City, Kansas, United States | Recruiting |
| MedStar | Baltimore, Maryland, United States | Recruiting |
| Tufts Medical Center | Boston, Massachusetts, United States | Recruiting |
+ 36 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05934487