PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
Condition(s) studied
Investigational drug(s) / intervention(s)
SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA: Patients will be implanted with a SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA heart valve
Study summary
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.
Eligibility
Primary outcome measure(s)
- Primary Effectiveness Endpoint — 2 years
Non-hierarchical composite of death, and heart failure hospitalization or event - Primary Safety Endpoint — 30 days
Non-hierarchical composite of death, stroke, life threatening or fatal bleeding, acute kidney injury stage 4, hospitalization due to device- or procedure-related complication, and valve dysfunction requiring reintervention
Trial sites (80)
| Facility | City | Region | Status |
|---|---|---|---|
| Heart Center LLC, Huntsville | Huntsville | Alabama | Recruiting |
| Tucson Medical Center | Tucson | Arizona | Active Not Recruiting |
| Cedars-Sinai Medical Center | Los Angeles | California | Recruiting |
| Huntington Hospital | Pasadena | California | Withdrawn |
| Eisenhower Desert Cardiology Center | Rancho Mirage | California | Recruiting |
| Bay Area Structural Heart at Sutter Health | San Francisco | California | Recruiting |
| Kaiser San Francisco Medical Center | San Francisco | California | Active Not Recruiting |
| University of California San Francisco | San Francisco | California | Recruiting |
| Santa Barbara Cottage Hospital | Santa Barbara | California | Recruiting |
| Stanford Univeristy | Stanford | California | Recruiting |
| UC Health Medical Center of the Rockies | Loveland | Colorado | Recruiting |
| Yale Universtiy | New Haven | Connecticut | Recruiting |
| The Cardiac & Vascular Institute Research Foundation | Gainesville | Florida | Withdrawn |
| Baptist Health Research Center | Jacksonville | Florida | Recruiting |
| Sarasota Memorial Health Care System | Sarasota | Florida | Recruiting |
| Emory University Atlanta | Atlanta | Georgia | Recruiting |
| Piedmont Heart Institute | Atlanta | Georgia | Recruiting |
| Saint Alphonsus | Boise | Idaho | Recruiting |
| Rush University Medical Center | Chicago | Illinois | Recruiting |
| Alexian Brothers Hospital | Lisle | Illinois | Recruiting |
| Ascension Via Christi St. Francis | Wichita | Kansas | Recruiting |
| Louisiana State University | New Orleans | Louisiana | Recruiting |
| Ochsner Clinical Foundation | New Orleans | Louisiana | Active Not Recruiting |
| Massachusetts General Hospital Boston | Boston | Massachusetts | Recruiting |
| Minneapolis Heart Institue, St. Paul's | Minneapolis | Minnesota | Recruiting |
| CentraCare Heart and Vascular Center | Saint Cloud | Minnesota | Recruiting |
| Saint Luke's Hospital of Kansas City Mid America | Kansas City | Missouri | Recruiting |
| St. Patrick Hospital | Missoula | Montana | Active Not Recruiting |
| Mary Hitchcock Memorial Hospital | Lebanon | New Hampshire | Recruiting |
| Atlantic Health System Hospital Corp - Morristown Medical Center | Morristown | New Jersey | Recruiting |
| Jersey Shore University Medical Center | Neptune City | New Jersey | Recruiting |
| Rutgers Robert Wood Johnson Medical School | New Brunswick | New Jersey | Recruiting |
| The Valley Hospital | Ridgewood | New Jersey | Recruiting |
| University of Buffalo Kaleida Health | Buffalo | New York | Recruiting |
| NYU Langone Hospital - Long Island | Mineola | New York | Recruiting |
| NYU Langone Health | New York | New York | Withdrawn |
| Columbia University Irving Medical Center/NYPH | New York | New York | Active Not Recruiting |
| Rochester General Hospital | Rochester | New York | Recruiting |
| St. Francis Hospital | Roslyn | New York | Recruiting |
| Montefiore Medical Center | The Bronx | New York | Recruiting |
+ 40 more sites — see the full list on the official registry below.
More Edwards Lifesciences trials in Japan
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04889872 on ClinicalTrials.gov ↗ ← All trials in Japan