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Active, not recruiting Not applicable Interventional

EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis

ClinicalTrials.gov ID: NCT03042104

Public ClinicalTrials.gov record NCT03042104. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 4:23 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Evaluation of Transcatheter Aortic Valve Replacement Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis.

Study identification

NCT ID
NCT03042104
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Edwards Lifesciences
Industry
Enrollment
901 participants

Conditions and interventions

Eligibility (public fields only)

Age range
65 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 12, 2017 (Actual)
Primary completion
Mar 31, 2024 (Actual)
Completion
Mar 2032 (Estimated)
Last update posted
May 13, 2024

2017 – 2032

United States locations

U.S. sites
74
U.S. states
32
U.S. cities
65
Facility City State ZIP Site status
Banner University Medical Center Phoenix Arizona 85006 —
Mills Peninsula Health Services Burlingame California 94010 —
Cedars-Sinai Medical Center Los Angeles California 90048 —
Hoag Memorial Hospital Presbyterian Newport Beach California 92663 —
Huntington Hospital Pasadena California 91105 —
UC Davis Medical Center Sacramento California 95817 —
Kaiser San Francisco Medical Center San Francisco California 94115 —
Stanford Hospital and Clinics Palo Alto Stanford California 94305 —
UC Health Northern Colorado (Medical Center of the Rockies) Loveland Colorado 80538 —
Yale University New Haven Connecticut 06510 —
Washington Hospital Center DC Washington D.C. District of Columbia 20010 —
The Cardiac & Vascular Institute Research Foundation Gainesville Florida 32605 —
University of Florida Gainesville Florida 32615 —
Piedmont Heart Institute Atlanta Georgia 30309 —
Emory University Atlanta Georgia 30322 —
Northwestern University Chicago Illinois 60611 —
Rush University Medical Center Chicago Chicago Illinois 60612 —
NorthShore University HealthSystem Research Institution Evanston Illinois 60201 —
Alexian Brothers Hospital Network Lisle Illinois 60532 —
Prairie Education and Research Cooperative Springfield Illinois 62701 —
University of Iowa Hospitals and Clinics Iowa City Iowa 52242 —
Iowa Heart Center West Des Moines Iowa 50266 —
Cardiovascular Research Institute of Kansas Wichita Kansas 67226 —
Ochsner Clinic Foundation New Orleans Louisiana 70121 —
Maine Medical Center Portland Maine 04102 —
University of Maryland Medical Center Baltimore Maryland 21201 —
Brigham and Women's Hospital Boston Massachusetts 02115 —
Cape Cod Hospital Hyannis Massachusetts 02601 —
Henry Ford Hospital Detroit Michigan 48202 —
Minneapolis Heart Institute Minneapolis Minnesota 55407 —
University of Minnesota Medical Center Minneapolis Minnesota 55455 —
Mayo Clinic Rochester Minnesota 55905 —
CentraCare Heart Saint Cloud Minnesota 56303 —
Saint Luke's Hospital of Kansas City Mid America Kansas City Missouri 64111 —
St. Patrick Hospital Missoula Montana 59802 —
Mary Hitchcock Memorial Hospital Lebanon New Hampshire 03756 —
Atlantic Health System Hospital Corp - Morristown Medical Center Morristown New Jersey 07960 —
Newark Beth Israel Medical Center Newark New Jersey 07112 —
Rutgers Robert Wood Johnson Medical School Piscataway New Jersey 08854 —
Albany Medical College Albany New York 12211 —
University at Buffalo - Kaleida Health Buffalo New York 14203 —
NYU Langone Hosptial - Long Island Mineola New York 11501 —
New York University Langone Medical Center New York New York 10016 —
Columbia University Medical Center/ New York Presbyterian Hospital New York New York 10032 —
Cornell University New York New York 10065 —
Rochester General Hospital Rochester New York 14621 —
Stony Brook University Medical Center Stony Brook New York 11794 —
Montefiore Medical Center The Bronx New York 10467 —
Carolina's Health System Charlotte North Carolina 28203 —
NC Heart and Vascular (Rex Hospital) Raleigh North Carolina 27607 —
The Christ Hospital, Cincinnati Cincinnati Ohio 45219 —
Cleveland Clinic Foundation Cleveland Ohio 44195 —
Mount Carmel Health System Columbus Ohio 43213 —
The Ohio Health Research Institute Columbus Ohio 43214 —
Kaiser Portland Clackamas Oregon 97015 —
Pinnacle Health Harrisburg Pennsylvania 17101 —
Allegheny - Singer Research Institute Pittsburgh Pennsylvania 15212 —
Lankenau Medical Center Wynnewood Pennsylvania 19096 —
York Hospital York Pennsylvania 17403 —
Vanderbilt University Medical Center Nashville Tennessee 37232 —
The Heart Hospital Baylor Plano Dallas Texas 75093 —
Texas Health Physician Group Dallas Texas 75231 —
University of Texas Health Science Center at Houston Houston Texas 77030 —
Intermountain Medical Center Salt Lake City Murray Utah 84107 —
University of Virginia Charlottesville Virginia 22908 —
Inova Heart and Vascular Institute (Fairfax Inova) Falls Church Virginia 22042 —
Sentara Cardiovascular Research Institute Norfolk Virginia 23507 —
Carilion Medical Center Roanoke Virginia 24014 —
Providence Everett Everett Washington 98201 —
Swedish Medical Center Seattle Washington 98122 —
University of Washington Seattle Washington 98195 —
Sacred Heart Medical Center Spokane Washington 99204 —
CAMC Clinical Trials Center Charleston West Virginia 25304 —
Medical College of Wisconsin Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03042104, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 13, 2024 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03042104 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →