ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent (NCT03130777)
Multicenter Study of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 THV With the Alterra Adaptive Prestent
🩺 Plain-English Summary (8th-Grade Level)
To demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract/pulmonary valve (RVOT/PV) who are indicated for treatment of pulmonary regurgitation (PR). Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
Who can join: Review the eligibility criteria below.
Location: Cedars-Sinai Medical Center — Los Angeles, California
🧪 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 (14 Sites)
- Cedars-Sinai Medical Center — Los Angeles, California
- University of California, Los Angeles — Los Angeles, California
- University of California, San Francisco — San Francisco, California
- Children's Hospital Colorado — Aurora, Colorado
- Emory University/ Children's Healthcare of Atlanta (CHOA) — Atlanta, Georgia
- St. Louis Children's Hospital — St Louis, Missouri
- Columbia University Medical Center — New York, New York
- Cincinnati Children's Hospital — Cincinnati, Ohio
- Nationwide Children's Hospital — Columbus, Ohio
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
- Children's Health Dallas — Dallas, Texas
- Texas Children's Hospital — Houston, Texas
- University of Virgina — Charlottesville, Virginia
- Seattle Children's Hospital — 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
- 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.