🏛️ Verified NIH Record • Updated 2026-06-03

ALT-FLOW II Trial of the Edwards APTURE Transcatheter Shunt System (NCT05686317)

A Randomized, Sham-controlled Clinical Trial for Evaluation of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW II)

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Edwards Lifesciences

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

This is a prospective, multi-center, randomized, sham-controlled, double-blinded (participant and outcomes assessor) clinical trial.

Who can join: Review the eligibility criteria below.

Location: University of California Irvine — Irvine, California

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (25 Sites)

  • University of California Irvine — Irvine, California
  • University of California San Diego — La Jolla, California
  • Scripps Health — La Jolla, California
  • University of Southern California — Los Angeles, California
  • University of California San Francisco — San Francisco, California
  • Ascension Illinois Heart and Vascular Medical Group — Elk Grove, Illinois
  • Kansas University Medical Center — Kansas City, Kansas
  • Abbott Northwestern Hospital — Minneapolis, Minnesota
  • Mayo Clinic — Rochester, Minnesota
  • St. Francis Hospital & Heart Center — Roslyn, New York
  • Montefiore Medical Center — The Bronx, New York
  • The Christ Hospital — Cincinnati, Ohio
  • The Ohio State University — Columbus, Ohio
  • Oklahoma Heart Institute — Tulsa, Oklahoma
  • Oregon Health and Science University — Oregon City, Oregon
  • Lankenau Medical Center — Wynnewood, Pennsylvania
  • Medical University of South Carolina Charleston — Charleston, South Carolina
  • Instituto do Coracao da Universidade de Sao Paulo — São Paulo,
  • The Ottawa Hospital — Ottawa, Canada
  • Herz- und Diabeteszentrum NRW - Bad Oeynhausen — Bad Oeynhausen,
  • Herzzentrum Universitätsklinikum Köln — Cologne,
  • Herzzentrum Dresden GmbH Universitätsklinik für Innere Medizin und Kardiologie — Dresden,
  • Universitätsklinikum Heidelberg Medizinische Klinik — Heidelberg,
  • Johannes Gutenberg Universitaet Mainz — Mainz,
  • Universitätsspital Basel — Basel,

💰 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.

Explore by condition: All Heart Failure clinical trials

💡 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.
🏛️ View Official NIH Record ↗