Recruiting

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

Sponsor:

Edwards Lifesciences

Code:

NCT04889872

Conditions

Aortic Stenosis, Calcific

Aortic Valve Stenosis

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA

Study Details

Brief 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.

Conditions

Aortic Stenosis, Calcific

Aortic Valve Stenosis

Study ID

NCT04889872

Start date

Oct 12, 2021

Status verified date

Oct, 2025

Completion date

Jun, 2037

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

2250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TAVR

Transcatheter Aortic Valve Replacement (TAVR)

no intervention: CS

Clinical Surveillance (CS)

Interventions

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

Primary outcome measure

Primary Effectiveness Endpoint [ Time Frame: 2 years ]
Primary Safety Endpoint [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Edwards THV Clinical Affairs

949-250-2500 THV_CT.gov@Edwards.com

Locations

Heart Center LLC, Huntsville

Recruiting

Huntsville, Alabama, United States, 35801

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Eisenhower Desert Cardiology Center

Recruiting

Rancho Mirage, California, United States, 92270

Bay Area Structural Heart at Sutter Health

Recruiting

San Francisco, California, United States, 94109

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Santa Barbara Cottage Hospital

Recruiting

Santa Barbara, California, United States, 93105

Stanford Univeristy

Recruiting

Stanford, California, United States, 94305

UC Health Medical Center of the Rockies

Recruiting

Loveland, Colorado, United States, 80538

Yale Universtiy

Recruiting

New Haven, Connecticut, United States, 06510

Baptist Health Research Center

Recruiting

Jacksonville, Florida, United States, 32207

Sarasota Memorial Health Care System

Recruiting

Sarasota, Florida, United States, 34239

Emory University Atlanta

Recruiting

Atlanta, Georgia, United States, 30308

Piedmont Heart Institute

Recruiting

Atlanta, Georgia, United States, 30309

Saint Alphonsus

Recruiting

Boise, Idaho, United States, 83704

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Alexian Brothers Hospital

Recruiting

Lisle, Illinois, United States, 60532

Ascension Via Christi St. Francis

Recruiting

Wichita, Kansas, United States, 67226

Louisiana State University

Recruiting

New Orleans, Louisiana, United States, 70112

Massachusetts General Hospital Boston

Recruiting

Boston, Massachusetts, United States, 02114

Minneapolis Heart Institue, St. Paul's

Recruiting

Minneapolis, Minnesota, United States, 55102

CentraCare Heart and Vascular Center

Recruiting

Saint Cloud, Minnesota, United States, 56303

Saint Luke's Hospital of Kansas City Mid America

Recruiting

Kansas City, Missouri, United States, 64111

Mary Hitchcock Memorial Hospital

Recruiting

Lebanon, New Hampshire, United States, 03756

Atlantic Health System Hospital Corp - Morristown Medical Center

Recruiting

Morristown, New Jersey, United States, 07960

Jersey Shore University Medical Center

Recruiting

Neptune City, New Jersey, United States, 07753

Rutgers Robert Wood Johnson Medical School

Recruiting

New Brunswick, New Jersey, United States, 08901

The Valley Hospital

Recruiting

Ridgewood, New Jersey, United States, 07450

University of Buffalo Kaleida Health

Recruiting

Buffalo, New York, United States, 14203

NYU Langone Hospital - Long Island

Recruiting

Mineola, New York, United States, 11501

Rochester General Hospital

Recruiting

Rochester, New York, United States, 14621

St. Francis Hospital

Recruiting

Roslyn, New York, United States, 11576

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Moses Cone Memorial Hospital

Recruiting

Greensboro, North Carolina, United States, 27401

Oklahoma Heart Institute

Recruiting

Tulsa, Oklahoma, United States, 74104

Legacy Emanuel Medical Center

Recruiting

Portland, Oregon, United States, 97227

Allegheny Singer Research Institute

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Lankenau Medical Center

Recruiting

Wynnewood, Pennsylvania, United States, 19096

Baptist Memorial Hospital Memphis

Recruiting

Germantown, Tennessee, United States, 38138

Methodist Le Bonheur Healthcare

Recruiting

Germantown, Tennessee, United States, 38138

Parkwest Medical Center

Recruiting

Knoxville, Tennessee, United States, 37923

Saint Thomas Health

Recruiting

Nashville, Tennessee, United States, 37205

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Ascension Texas Cardiovascular

Recruiting

Austin, Texas, United States, 78705

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75235

HCA Houston Healthcare Medical Center

Recruiting

Houston, Texas, United States, 77004

The University of Texas Health Science Center

Recruiting

Houston, Texas, United States, 77030

The Heart Hospital Baylor Plano

Recruiting

Plano, Texas, United States, 75093

Kaiser Mid Atlantic

Recruiting

McLean, Virginia, United States, 22102

Sentara Norfolk General Hospital

Recruiting

Norfolk, Virginia, United States, 23507

Swedish Medical Center

Recruiting

Seattle, Washington, United States, 98112

More Information

Sponsor

Edwards Lifesciences

Last update posted

Dec 17, 2025

Last verified

Oct, 2025

Keywords

Transcatheter aortic valve replacement (TAVR)
SAPIEN 3
SAPIEN 3 Ultra
SAPIEN 3 Ultra RESILIA
Moderate aortic stenosis
Aortic stenosis
Transcatheter heart valve

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Edwards Lifesciences on 2025-12-17.