Active, not recruitingNCT03042104

EARLY TAVR

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

Edwards LifesciencesMultiple US sitesView on ClinicalTrials.gov

AI Description

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.

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Who can join
older adult
Participants
901
Expected completion
2032-03
Funded by
industry

Conditions studied

Aortic Stenosis, Severe, Heart Diseases

What is being tested

  • DEVICE: Edwards SAPIEN 3 / SAPIEN 3 Ultra THV

What it measures

  • All-cause death, all stroke, and unplanned cardiovascular hospitalization, The number of patients that have any of these conditions, When all patients have reached 2-year follow-up

Centers Participating

These centers are participating in this study. Reach out to them directly to learn more.

Abbott Northwestern Hospital

Minneapolis, MN

Albany Medical Center

Albany, NY

Allegheny General Hospital

Pittsburgh, PA

Atrium Health Carolinas Medical Center

Charlotte, NC

Banner – University Medical Center Phoenix

Phoenix, AZ

Baylor Scott & White The Heart Hospital – Plano

Plano, TX

Brigham and Women's Hospital

Boston, MA

Cape Cod Hospital

Hyannis, MA

Carilion Roanoke Memorial Hospital

Roanoke, VA

Cedars-Sinai Medical Center

Los Angeles, CA

CentraCare – St. Cloud Hospital

Saint Cloud, MN

Charleston Area Medical Center

Charleston, WV

Cleveland Clinic

Cleveland, OH

Dartmouth Hitchcock Medical Center (Lebanon)

Lebanon, NH

Emory University Hospital

Atlanta, GA

Endeavor Health Evanston Hospital

Evanston, IL

Froedtert Hospital

Milwaukee, WI

HCA Florida North Florida Hospital

Gainesville, FL

Henry Ford Health (Detroit)

Detroit, MI

Hoag Hospital (Newport Beach)

Newport Beach, CA

HSHS St. John's Hospital

Springfield, IL

Huntington Hospital

Pasadena, CA

Inova Fairfax Medical Campus

Falls Church, VA

Intermountain Medical Center

Murray, UT

Kaiser Permanente San Francisco Medical Center

San Francisco, CA

Kaleida Health

Buffalo, NY

Lankenau Medical Center

Wynnewood, PA

M Health Fairview University of Minnesota Medical Center (East Bank)

Minneapolis, MN

MaineHealth Maine Medical Center (Portland)

Portland, ME

Mayo Clinic (Rochester, Minnesota)

Rochester, MN

MedStar Washington Hospital Center

Washington, DC

Memorial Hermann-Texas Medical Center

Houston, TX

Mills-Peninsula Medical Center

Burlingame, CA

Montefiore Einstein Hospital (Moses Campus)

Bronx, NY

Morristown Medical Center

Morristown, NJ

Mount Carmel East

Columbus, OH

Newark Beth Israel Medical Center

Newark, NJ

NewYork-Presbyterian Hospital

New York, NY

Northwestern Memorial Hospital

Chicago, IL

Ochsner Medical Center – New Orleans

New Orleans, LA

OhioHealth Riverside Methodist Hospital

Columbus, OH

Piedmont Atlanta Hospital

Atlanta, GA

Providence Regional Medical Center Everett

Everett, WA

Providence Sacred Heart Medical Center & Children's Hospital

Spokane, WA

Providence St. Patrick Hospital

Missoula, MT

Rochester General Hospital

Rochester, NY

Rush University Medical Center

Chicago, IL

Saint Luke’s Hospital of Kansas City

Kansas City, MO

Sentara Norfolk General Hospital

Norfolk, VA

Stanford Health Care

Stanford, CA

Stony Brook University Hospital

Stony Brook, NY

Swedish Cherry Hill Campus

Seattle, WA

Texas Health Dallas

Dallas, TX

The Christ Hospital

Cincinnati, OH

UC Davis Medical Center

Sacramento, CA

UCHealth Medical Center of the Rockies

Loveland, CO

UF Health Shands Hospital

Gainesville, FL

UNC Health Rex (Raleigh)

Raleigh, NC

University Medical Center

Charlottesville, VA

University of Iowa Health Care

Iowa City, IA

University of Maryland Medical Center

Baltimore, MD

University of Washington Medical Center

Seattle, WA

UPMC Harrisburg

Harrisburg, PA

Vanderbilt University Medical Center

Nashville, TN

WellSpan York Hospital

York, PA

Yale New Haven Hospital

New Haven, CT

Data Sources and Methodology

Registry entry updated 2024-05-13

Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.

If you would rather we did it with you, call us on (656) 206-4686.