Phase
Condition
N/ATreatment
SAPIEN 3 / SAPIEN 3 Ultra
SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA
Clinical Study ID
Ages > 65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
65 years of age or older at time of randomization
Moderate aortic stenosis
Subject has symptoms or evidence of cardiac damage/dysfunction
The subject or subject's legal representative has been informed of the nature of thestudy, agrees to its provisions, and has provided written informed consent.
Exclusion
Key Exclusion Criteria:
Native aortic annulus size unsuitable for the THV
Anatomical characteristics that would preclude safe transfemoral placement of theintroducer sheath or safe passage of the delivery system
Aortic valve is unicuspid or non-calcified
Bicuspid aortic valve with an aneurysmal ascending aorta > 4.5 cm or severeraphe/leaflet calcification
Pre-existing mechanical or bioprosthetic aortic valve
Severe aortic regurgitation
Prior balloon aortic valvuloplasty to treat severe AS
LVEF < 20%
Left ventricular outflow tract calcification that would increase the risk of annularrupture or significant paravalvular leak post-TAVR
Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
Coronary or aortic valve anatomy that increases the risk of coronary arteryobstruction post-TAVR
Study Design
Study Description
Connect with a study center
The Prince Charles Hospital
Chermside, Queensland 4032
AustraliaSite Not Available
Royal Adelaide Hospital
Adelaide, South Australia 5000
AustraliaSite Not Available
Flinders Medical Centre
Bedford Park, South Australia 5042
AustraliaSite Not Available
Monash Health
Clayton, Victoria 3168
AustraliaSite Not Available
St. Paul's Hospital
Vancouver, British Columbia V6E1M7
CanadaSite Not Available
Hamiton Health Services
Hamilton, Onterio L8L 2X2
CanadaSite Not Available
Kokura Memorial Hospital
Fukuoka, Kyushu 802-8555
JapanSite Not Available
Sendai Kousei Hospital
Sendai, Miyagi 981-0914
JapanSite Not Available
Sakakibara Heart Institute
Fuchu, Tokyo 183-0003
JapanSite Not Available
Keio University Hospital
Shinjuku, Tokyo 160-8582
JapanSite Not Available
AMC Amsterdam
Amsterdam, North Holland 1105 AZ
NetherlandsSite Not Available
Leiden Universitair Medisch Centrum
Leiden, South Holland 2333
NetherlandsSite Not Available
Erasmus Rotterdam
Rotterdam, South Holland 3015
NetherlandsSite Not Available
Hôpitaux Universitaire de Genève
Geneva, 1205
SwitzerlandSite Not Available
Universitätsspital Zürich
Zürich, 8091
SwitzerlandSite Not Available
Heart Center LLC, Huntsville
Huntsville, Alabama 35801
United StatesActive - Recruiting
Tucson Medical Center
Tucson, Arizona 85712
United StatesSite Not Available
Cedars-Sinai Medical Center
Los Angeles, California 90048
United StatesActive - Recruiting
Huntington Hospital
Pasadena, California 91105
United StatesSite Not Available
Eisenhower Desert Cardiology Center
Rancho Mirage, California 92270
United StatesActive - Recruiting
Bay Area Structural Heart at Sutter Health
San Francisco, California 94109
United StatesActive - Recruiting
Kaiser San Francisco Medical Center
San Francisco, California 94118
United StatesSite Not Available
University of California San Francisco
San Francisco, California 94143
United StatesActive - Recruiting
Santa Barbara Cottage Hospital
Santa Barbara, California 93105
United StatesSite Not Available
Stanford Univeristy
Stanford, California 94305
United StatesActive - Recruiting
UC Health Medical Center of the Rockies
Loveland, Colorado 80538
United StatesActive - Recruiting
Yale Universtiy
New Haven, Connecticut 06510
United StatesActive - Recruiting
The Cardiac & Vascular Institute Research Foundation
Gainesville, Florida 32605
United StatesSite Not Available
Baptist Health Research Center
Jacksonville, Florida 32207
United StatesActive - Recruiting
Sarasota Memorial Health Care System
Sarasota, Florida 34239
United StatesActive - Recruiting
Emory University Atlanta
Atlanta, Georgia 30308
United StatesSite Not Available
Piedmont Heart Institute
Atlanta, Georgia 30309
United StatesActive - Recruiting
Saint Alphonsus
Boise, Idaho 83704
United StatesActive - Recruiting
Rush University Medical Center
Chicago, Illinois 60612
United StatesSite Not Available
Alexian Brothers Hospital
Lisle, Illinois 60532
United StatesActive - Recruiting
Ascension Via Christi St. Francis
Wichita, Kansas 67226
United StatesActive - Recruiting
Cardiovascular Research Institute of Kansas
Wichita, Kansas 67226
United StatesActive - Recruiting
Louisiana State University
New Orleans, Louisiana 70112
United StatesActive - Recruiting
Ochsner Clinical Foundation
New Orleans, Louisiana 70121
United StatesSite Not Available
Massachusetts General Hospital Boston
Boston, Massachusetts 02114
United StatesActive - Recruiting
Minneapolis Heart Institue, St. Paul's
Minneapolis, Minnesota 55102
United StatesActive - Recruiting
CentraCare Heart and Vascular Center
Saint Cloud, Minnesota 56303
United StatesActive - Recruiting
Saint Luke's Hospital of Kansas City Mid America
Kansas City, Missouri 64111
United StatesActive - Recruiting
St. Patrick Hospital
Missoula, Montana 59802
United StatesSite Not Available
Mary Hitchcock Memorial Hospital
Lebanon, New Hampshire 03756
United StatesActive - Recruiting
Atlantic Health System Hospital Corp - Morristown Medical Center
Morristown, New Jersey 07960
United StatesActive - Recruiting
Jersey Shore University Medical Center
Neptune, New Jersey 07753
United StatesSite Not Available
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey 08901
United StatesActive - Recruiting
The Valley Hospital
Ridgewood, New Jersey 07450
United StatesActive - Recruiting
Montefiore Medical Center
Bronx, New York 10467
United StatesActive - Recruiting
University of Buffalo Kaleida Health
Buffalo, New York 14203
United StatesActive - Recruiting
NYU Langone Hospital - Long Island
Mineola, New York 11501
United StatesActive - Recruiting
Columbia University Irving Medical Center/NYPH
New York, New York 10032
United StatesSite Not Available
NYU Langone Health
New York, New York 10016
United StatesSite Not Available
Rochester General Hospital
Rochester, New York 14621
United StatesActive - Recruiting
St. Francis Hospital
Roslyn, New York 11576
United StatesActive - Recruiting
Moses Cone Memorial Hospital
Greensboro, North Carolina 27401
United StatesActive - Recruiting
The Christ Hospital
Cincinnati, Ohio 45219
United StatesSite Not Available
Mount Carmel Health System
Columbus, Ohio 43213
United StatesSite Not Available
Oklahoma Heart Institute
Tulsa, Oklahoma 74104
United StatesActive - Recruiting
Kaiser Permanente Northwest
Clackamas, Oregon 97015
United StatesSite Not Available
Legacy Emanuel Medical Center
Portland, Oregon 97227
United StatesActive - Recruiting
Providence Heart & Vascular Institute Portland
Portland, Oregon 97225
United StatesSite Not Available
Allegheny Singer Research Institute
Pittsburgh, Pennsylvania 15212
United StatesActive - Recruiting
UPMC Presbyterian Shadyside
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Pinnacle Health Harrisburg
Wormleysburg, Pennsylvania 17043
United StatesSite Not Available
Lankenau Medical Center
Wynnewood, Pennsylvania 19096
United StatesActive - Recruiting
Baptist Memorial Hospital Memphis
Germantown, Tennessee 38138
United StatesActive - Recruiting
Methodist Le Bonheur Healthcare
Germantown, Tennessee 38138
United StatesSite Not Available
Parkwest Medical Center
Knoxville, Tennessee 37923
United StatesSite Not Available
Saint Thomas Health
Nashville, Tennessee 37205
United StatesActive - Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesActive - Recruiting
Ascension Texas Cardiovascular
Austin, Texas 78705
United StatesActive - Recruiting
UT Southwestern Medical Center
Dallas, Texas 75235
United StatesActive - Recruiting
HCA Houston Healthcare Medical Center
Houston, Texas 77004
United StatesActive - Recruiting
The University of Texas Health Science Center
Houston, Texas 77030
United StatesActive - Recruiting
The Heart Hospital Baylor Plano
Plano, Texas 75093
United StatesActive - Recruiting
Methodist Hospital of San Antonio
San Antonio, Texas 78229
United StatesSite Not Available
Kaiser Mid Atlantic
McLean, Virginia 22102
United StatesActive - Recruiting
Sentara Norfolk General Hospital
Norfolk, Virginia 23507
United StatesActive - Recruiting
Swedish Medical Center
Seattle, Washington 98112
United StatesActive - Recruiting
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