🏛️ Verified NIH Record • Updated 2024-05-10
EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis (NCT03042104)
Evaluation of Transcatheter Aortic Valve Replacement Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis
🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Edwards Lifesciences
🩺 Plain-English Summary (8th-Grade Level)
This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis.
Who can join: Review the eligibility criteria below.
Location: Banner University Medical Center — Phoenix, Arizona
Age range: 65 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 (77 Sites)
Showing the first 25 of 77 sites.
- Banner University Medical Center — Phoenix, Arizona
- Mills Peninsula Health Services — Burlingame, California
- Cedars-Sinai Medical Center — Los Angeles, California
- Hoag Memorial Hospital Presbyterian — Newport Beach, California
- Huntington Hospital — Pasadena, California
- UC Davis Medical Center — Sacramento, California
- Kaiser San Francisco Medical Center — San Francisco, California
- Stanford Hospital and Clinics Palo Alto — Stanford, California
- UC Health Northern Colorado (Medical Center of the Rockies) — Loveland, Colorado
- Yale University — New Haven, Connecticut
- Washington Hospital Center DC — Washington D.C., District of Columbia
- The Cardiac & Vascular Institute Research Foundation — Gainesville, Florida
- University of Florida — Gainesville, Florida
- Piedmont Heart Institute — Atlanta, Georgia
- Emory University — Atlanta, Georgia
- Northwestern University — Chicago, Illinois
- Rush University Medical Center Chicago — Chicago, Illinois
- NorthShore University HealthSystem Research Institution — Evanston, Illinois
- Alexian Brothers Hospital Network — Lisle, Illinois
- Prairie Education and Research Cooperative — Springfield, Illinois
- University of Iowa Hospitals and Clinics — Iowa City, Iowa
- Iowa Heart Center — West Des Moines, Iowa
- Cardiovascular Research Institute of Kansas — Wichita, Kansas
- Ochsner Clinic Foundation — New Orleans, Louisiana
- Maine Medical Center — Portland, Maine
💰 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.