Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients (NCT02701283)
Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement
🩺 Plain-English Summary (8th-Grade Level)
The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR. The purpose of the expanded use addendum to the Medtronic TAVR in Low Risk Patients Trial protocol is to conclude the randomized phase of the trial and initiate the single-arm, non-randomized, continued access phase of the trial.
Who can join: Review the eligibility criteria below.
Location: Abrazo Arizona Heart Hospital — Phoenix, Arizona
🧪 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 (87 Sites)
Showing the first 25 of 87 sites.
- Abrazo Arizona Heart Hospital — Phoenix, Arizona
- Scripps Memorial Hospital La Jolla — La Jolla, California
- University of Southern California University Hospital — Los Angeles, California
- El Camino Hospital — Mountain View, California
- Mercy General Hospital — Sacramento, California
- Los Robles Hospital & Medical Center — Thousand Oaks, California
- University of Colorado Hospital — Aurora, Colorado
- Yale New Haven Hospital — New Haven, Connecticut
- Morton Plant Hospital — Clearwater, Florida
- Delray Medical Center — Delray Beach, Florida
- HealthPark Medical Center — Fort Myers, Florida
- University of Miami Hospital — Miami, Florida
- Tallahassee Research Institute, Inc. — Tallahassee, Florida
- Piedmont Atlanta Hospital — Atlanta, Georgia
- Loyola University Medical Center — Maywood, Illinois
- Saint Vincent Heart Center of Indiana — Indianapolis, Indiana
- Mercy Medical Center — Des Moines, Iowa
- The University of Kansas Hospital — Kansas City, Kansas
- Jewish Hospital — Louisville, Kentucky
- Terrebonne General Medical Center — Houma, Louisiana
- University of Maryland Medical Center — Baltimore, Maryland
- MedStar Union Memorial Hospital — Baltimore, Maryland
- The Johns Hopkins Hospital — Baltimore, Maryland
- Massachusetts General Hospital — Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
💰 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.
More studies in Aortic Valve Stenosis
- ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis — Los Angeles, California
- Prolonged Continuous ECG Monitoring Prior to Transcatheter Aortic Valve Implantation — Québec, Quebec
- Inspiris Resilia Durability Registry — Sankt Pölten,
- Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD) — Chandler, Arizona
- Platelet Adhesion in the Pathobiology of Aortic Stenosis — Charlottesville, Virginia
Explore by condition: All Aortic Valve Stenosis clinical trials
💡 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.