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Clinical Trials in the USA / NCT04889872
Recruiting Not applicable

PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR

NCT04889872 · tracked via the Priya Life Science USA tracker
Sponsor
Edwards Lifesciences
Phase
Not applicable
Started
2021-10-12
Last updated
2025-12-17

Condition(s) studied

Aortic Stenosis, CalcificAortic Valve Stenosis

Investigational drug(s) / intervention(s)

SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA

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

Sex
ALL
Min age
65 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: 1. 65 years of age or older at time of randomization 2. Moderate aortic stenosis 3. Subject has symptoms or evidence of cardiac damage/dysfunction 4. The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent. Key Exclusion Criteria: 1. Native aortic annulus size unsuitable for the THV 2. Anatomical characteristics that would preclude safe transfemoral placement of the introducer sheath or safe passage of the delivery system 3. Aortic valve is unicuspid or non-calcified 4. Bicuspid aortic valve with an aneurysmal ascending aorta \> 4.5 cm or severe raphe/leaflet calcification 5. Pre-existing mechanical or bioprosthetic aortic valve 6. Severe aortic regurgitation 7. Prior balloon aortic valvuloplasty to treat severe AS 8. LVEF \< 20% 9. Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post-TAVR 10. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation 11. Coronary or aortic valve anatomy that increases the risk of coronary artery obstruction post-TAVR

Primary outcome measure(s)

Trial sites (80)

FacilityCityRegionStatus
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 the USA

Other trials for the same condition

Official registry record

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 the USA