PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III (NCT05934487)
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 II-III Heart Failure Patients
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: St. Joseph's Hospital and Medical Center — Phoenix, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (48 Sites)
Showing the first 25 of 48 sites.
- St. Joseph's Hospital and Medical Center — Phoenix, Arizona
- USC — Los Angeles, California
- UCSF Medical Center — San Francisco, California
- Baptist Health South Florida — Miami, Florida
- Ascension Sacred Heart — Pensacola, Florida
- Piedmont — Atlanta, Georgia
- Advocate Health System — Downers Grove, Illinois
- Heart Care Centers of Illinois (HCCI) — Palos Park, Illinois
- Ascension St. Vincent's — Indianapolis, Indiana
- University of Kansas Medical Center (KUMC) — Kansas City, Kansas
- MedStar — Baltimore, Maryland
- Tufts Medical Center — Boston, Massachusetts
- Boston Medical Center Corporation — Boston, Massachusetts
- Ascension Providence Hospital Cardiology - Heart Cardiology — Howell, Michigan
- University of Minnesota — Minneapolis, Minnesota
- Centra Care Heart Center — Saint Cloud, Minnesota
- St. Lukes/ Mid-American Heart Institute — Kansas City, Missouri
- Mount Sinai West — New York, New York
- Mount Sinai — New York, New York
- Lenox Hill/ Northwell Health — New York, New York
- Stony Brook University Med Center — Stony Brook, New York
- UNC Medical Center — Durham, North Carolina
- Duke University — Durham, North Carolina
- The Christ Hospital- Cincinnati — Cincinnati, Ohio
- University of Cincinnati — Cincinnati, Ohio
📞 Contact the Study Coordinator
Phone: (630) 473-3200
Email: sarah_walton@edwards.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Heart Failure NYHA Class II
- Early Metabolic Adaptations to SGLT2 Inhibition in Heart Failure — Philadelphia, Pennsylvania
Explore by condition: All Heart Failure NYHA Class II clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.