PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
Recruiting now · Not applicable
Conditions studied: Aortic Stenosis, Calcific, Aortic Valve Stenosis
In brief
This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects with moderate, calcific aortic stenosis. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
Key facts
- Study ID
- NCT04889872
- Run by
- Edwards Lifesciences
- People needed
- 2250
- Starts
- 2021-10-12
- Expected to finish
- 2037-06-01
- Last updated by the study team
- 2025-12-17
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Saint Luke's Hospital of Kansas City Mid America — Kansas City, Missouri, United States (enrolling)
- Atlantic Health System Hospital Corp - Morristown Medical Center — Morristown, New Jersey, United States (enrolling)
- Heart Center LLC, Huntsville — Huntsville, Alabama, United States (enrolling)
- CentraCare Heart and Vascular Center — Saint Cloud, Minnesota, United States (enrolling)
- Mary Hitchcock Memorial Hospital — Lebanon, New Hampshire, United States (enrolling)
- Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
- University of California San Francisco — San Francisco, California, United States (enrolling)
- Santa Barbara Cottage Hospital — Santa Barbara, California, United States (enrolling)
- Stanford Univeristy — Stanford, California, United States (enrolling)
- Eisenhower Desert Cardiology Center — Rancho Mirage, California, United States (enrolling)
- Yale Universtiy — New Haven, Connecticut, United States (enrolling)
- Bay Area Structural Heart at Sutter Health — San Francisco, California, United States (enrolling)
- Baptist Health Research Center — Jacksonville, Florida, United States (enrolling)
- Sarasota Memorial Health Care System — Sarasota, Florida, United States (enrolling)
- Emory University Atlanta — Atlanta, Georgia, United States (enrolling)
- Piedmont Heart Institute — Atlanta, Georgia, United States (enrolling)
- Saint Alphonsus — Boise, Idaho, United States (enrolling)
- Rush University Medical Center — Chicago, Illinois, United States (enrolling)
- Alexian Brothers Hospital — Lisle, Illinois, United States (enrolling)
- Ascension Via Christi St. Francis — Wichita, Kansas, United States (enrolling)
- Louisiana State University — New Orleans, Louisiana, United States (enrolling)
- UC Health Medical Center of the Rockies — Loveland, Colorado, United States (enrolling)
- Massachusetts General Hospital Boston — Boston, Massachusetts, United States (enrolling)
- Minneapolis Heart Institue, St. Paul's — Minneapolis, Minnesota, United States (enrolling)
- Jersey Shore University Medical Center — Neptune City, New Jersey, United States (enrolling)
Full record on ClinicalTrials.gov
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