Early Feasibility Study - Edwards APTURE Transcatheter Shunt System (NCT03523416)

🧪 Interventions in This Study

• Transcatheter Atrial Shunt System (DEVICE)

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

📍 All Participating Trial Locations (15 Sites)

• UC San Diego Health — La Jolla, California
• University California San Francisco — San Francisco, California
• University of Florida Health - Jacksonville — Jacksonville, Florida
• St. Vincent Medical Group — Indianapolis, Indiana
• Kansas University Medical Center — Kansas City, Kansas
• Abbott Northwestern — Minneapolis, Minnesota
• Mayo Clinic — Rochester, Minnesota
• Montefiore Medical Center — The Bronx, New York
• Atrium Health — Charlotte, North Carolina
• The Christ Hospital — Cincinnati, Ohio
• The Ohio State University Medical Center — Columbus, Ohio
• Oregon Health and Science University — Portland, Oregon
• Lankenau Institute for Medical Research — Wynnewood, Pennsylvania
• Medical University of South Carolina — Charleston, South Carolina
• Swedish Medical Center — Seattle, Washington

💰 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

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.