πŸ›οΈ Verified NIH Record β€’ Updated 2026-07-22

PROACTIVE-HF IDE Trial Heart Failure NYHA Class III (NCT04089059)

A Prospective, Multi-Center, Open Label, Single Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordellaβ„’ Pulmonary Artery Sensor System in NYHA Class III Heart Failure Patients (PROACTIVE- HF Trial)

πŸ”΅ Active, Not Recruiting Observational / Diagnostic βš™οΈ Medical Device Protocol Sponsor: Endotronix, Inc.

🩺 Plain-English Summary (8th-Grade Level)

This is a prospective, open- label, single arm, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System in NYHA Class III Heart Failure Patients compared to a Performance Goal (PG).

Who can join: Review the eligibility criteria below.

Location: Ascension St Vincent's β€” Birmingham, Alabama

Age range: 18 Years

πŸ§ͺ Interventions in This Study

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria β†—

πŸ“ All Participating Trial Locations (74 Sites)

Showing the first 25 of 74 sites.

  • Ascension St Vincent's β€” Birmingham, Alabama
  • Huntsville Hospital β€” Huntsville, Alabama
  • Phoenix Cardiovascular Research Group/Insight β€” Phoenix, Arizona
  • Loma Linda University β€” Loma Linda, California
  • Eisenhower Medical Center β€” Rancho Mirage, California
  • UCSD β€” San Diego, California
  • Kaiser San Francisco β€” San Francisco, California
  • UCSF Medical Center β€” San Francisco, California
  • Kaiser Santa Clara β€” Santa Clara, California
  • South Denver Cardiology β€” Littleton, Colorado
  • Hartford Hospital β€” Hartford, Connecticut
  • Baptist Health South Florida β€” Miami, Florida
  • Ascension Sacred Heart β€” Pensacola, Florida
  • USF Health β€” Tampa, Florida
  • Cleveland Clinic β€” Weston, Florida
  • Piedmont Athens β€” Athens, Georgia
  • Queens Medical Center β€” Honolulu, Hawaii
  • Northwestern β€” Chicago, Illinois
  • U of Chicago β€” Chicago, Illinois
  • Heart Centers of Illinois β€” Palos Park, Illinois
  • OSF Healthcare β€” Peoria, Illinois
  • Ascension St Vincent's β€” Indianapolis, Indiana
  • University of Iowa Medical Center β€” Iowa City, Iowa
  • University of Kansas Medical Center (KUMC) β€” Kansas City, Kansas
  • University Of Louisville β€” Louisville, Kentucky

πŸ’° 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 Β§ 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.

πŸ’‘ How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
πŸ›οΈ View Official NIH Record β†—