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Purpose

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

Eligibility

Eligible Ages
Over 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
TAVR 		Transcatheter Aortic Valve Replacement (TAVR)
  • Device: 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
No Intervention
CS 		Clinical Surveillance (CS)

Recruiting Locations

Heart Center LLC, Huntsville
Huntsville, Alabama 35801

Cedars-Sinai Medical Center
Los Angeles, California 90048

Eisenhower Desert Cardiology Center
Rancho Mirage, California 92270

Bay Area Structural Heart at Sutter Health
San Francisco, California 94109

University of California San Francisco
San Francisco, California 94143

Santa Barbara Cottage Hospital
Santa Barbara, California 93105

Stanford Univeristy
Stanford, California 94305

UC Health Medical Center of the Rockies
Loveland, Colorado 80538

Yale Universtiy
New Haven, Connecticut 06510

Baptist Health Research Center
Jacksonville, Florida 32207

Sarasota Memorial Health Care System
Sarasota, Florida 34239

Emory University Atlanta
Atlanta, Georgia 30308

Piedmont Heart Institute
Atlanta, Georgia 30309

Saint Alphonsus
Boise, Idaho 83704

Rush University Medical Center
Chicago, Illinois 60612

Alexian Brothers Hospital
Lisle, Illinois 60532

Ascension Via Christi St. Francis
Wichita, Kansas 67226

Louisiana State University
New Orleans, Louisiana 70112

Massachusetts General Hospital Boston
Boston, Massachusetts 02114

Minneapolis Heart Institue, St. Paul's
Minneapolis, Minnesota 55102

CentraCare Heart and Vascular Center
Saint Cloud, Minnesota 56303

Saint Luke's Hospital of Kansas City Mid America
Kansas City, Missouri 64111

Mary Hitchcock Memorial Hospital
Lebanon, New Hampshire 03756

Atlantic Health System Hospital Corp - Morristown Medical Center
Morristown, New Jersey 07960

Jersey Shore University Medical Center
Neptune City, New Jersey 07753

Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey 08901

The Valley Hospital
Ridgewood, New Jersey 07450

University of Buffalo Kaleida Health
Buffalo, New York 14203

NYU Langone Hospital - Long Island
Mineola, New York 11501

Rochester General Hospital
Rochester, New York 14621

St. Francis Hospital
Roslyn, New York 11576

Montefiore Medical Center
The Bronx, New York 10467

Moses Cone Memorial Hospital
Greensboro, North Carolina 27401

Oklahoma Heart Institute
Tulsa, Oklahoma 74104

Legacy Emanuel Medical Center
Portland, Oregon 97227

Allegheny Singer Research Institute
Pittsburgh, Pennsylvania 15212

Lankenau Medical Center
Wynnewood, Pennsylvania 19096

Baptist Memorial Hospital Memphis
Germantown, Tennessee 38138

Methodist Le Bonheur Healthcare
Germantown, Tennessee 38138

Parkwest Medical Center
Knoxville, Tennessee 37923

Saint Thomas Health
Nashville, Tennessee 37205

Vanderbilt University Medical Center
Nashville, Tennessee 37232

Ascension Texas Cardiovascular
Austin, Texas 78705

UT Southwestern Medical Center
Dallas, Texas 75235

HCA Houston Healthcare Medical Center
Houston, Texas 77004

The University of Texas Health Science Center
Houston, Texas 77030

The Heart Hospital Baylor Plano
Plano, Texas 75093

Kaiser Mid Atlantic
McLean, Virginia 22102

Sentara Norfolk General Hospital
Norfolk, Virginia 23507

Swedish Medical Center
Seattle, Washington 98112

More Details

Status
Recruiting
Sponsor
Edwards Lifesciences

Study Contact

Edwards THV Clinical Affairs
949-250-2500
THV_CT.gov@Edwards.com

Detailed Description

This is a prospective, randomized, controlled, multicenter study. Subjects will be randomized to either transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 / SAPIEN 3 Ultra /SAPIEN 3 Ultra RESILIA THV or Clinical Surveillance.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.