🏛️ 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 ChecklistFull 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.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.