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
The Prince Charles Hospital
Chermside 6943582, Queensland 2152274 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
Royal Adelaide Hospital
Adelaide 2078025, South Australia 2061327 5000
AustraliaSite Not Available
Flinders Medical Centre
Bedford Park 2076918, South Australia 2061327 5042
AustraliaSite Not Available
Monash Health
Clayton, Victoria 3168
AustraliaSite Not Available
Monash Health
Clayton 2171400, Victoria 2145234 3168
AustraliaSite Not Available
St. Paul's Hospital
Vancouver, British Columbia V6E1M7
CanadaSite Not Available
St. Paul's Hospital
Vancouver 6173331, British Columbia 5909050 V6E1M7
CanadaSite Not Available
Hamiton Health Services
Hamilton, Onterio L8L 2X2
CanadaSite Not Available
Hamiton Health Services
Hamilton 5969782, Onterio L8L 2X2
CanadaSite Not Available
Kokura Memorial Hospital
Fukuoka, Kyushu 802-8555
JapanSite Not Available
Kokura Memorial Hospital
Fukuoka 1863967, Kyushu 802-8555
JapanSite Not Available
Sendai Kousei Hospital
Sendai, Miyagi 981-0914
JapanSite Not Available
Sendai Kousei Hospital
Sendai 2111149, Miyagi 2111888 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
Sakakibara Heart Institute
Fuchū 11611632, Tokyo 1850144 183-0003
JapanSite Not Available
Keio University Hospital
Shinjuku 11790353, Tokyo 1850144 160-8582
JapanSite Not Available
AMC Amsterdam
Amsterdam, North Holland 1105 AZ
NetherlandsSite Not Available
AMC Amsterdam
Amsterdam 2759794, North Holland 2749879 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
Leiden Universitair Medisch Centrum
Leiden 2751773, South Holland 2743698 2333
NetherlandsSite Not Available
Erasmus Rotterdam
Rotterdam 2747891, South Holland 2743698 3015
NetherlandsSite Not Available
Hôpitaux Universitaire de Genève
Geneva, 1205
SwitzerlandSite Not Available
Hôpitaux Universitaire de Genève
Geneva 2660646, 1205
SwitzerlandSite Not Available
Universitätsspital Zürich
Zurich 2657896, 8091
SwitzerlandSite Not Available
Universitätsspital Zürich
Zürich, 8091
SwitzerlandSite Not Available
Heart Center LLC, Huntsville
Huntsville, Alabama 35801
United StatesSite Not Available
Heart Center LLC, Huntsville
Huntsville 4068590, Alabama 4829764 35801
United StatesActive - Recruiting
Tucson Medical Center
Tucson, Arizona 85712
United StatesSite Not Available
Tucson Medical Center
Tucson 5318313, Arizona 5551752 85712
United StatesSite Not Available
Cedars-Sinai Medical Center
Los Angeles, California 90048
United StatesSite Not Available
Huntington Hospital
Pasadena, California 91105
United StatesSite Not Available
Eisenhower Desert Cardiology Center
Rancho Mirage, California 92270
United StatesSite Not Available
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 StatesSite Not Available
Santa Barbara Cottage Hospital
Santa Barbara, California 93105
United StatesSite Not Available
Stanford Univeristy
Stanford, California 94305
United StatesSite Not Available
Cedars-Sinai Medical Center
Los Angeles 5368361, California 5332921 90048
United StatesActive - Recruiting
Huntington Hospital
Pasadena 5381396, California 5332921 91105
United StatesSite Not Available
Eisenhower Desert Cardiology Center
Rancho Mirage 5386015, California 5332921 92270
United StatesActive - Recruiting
Bay Area Structural Heart at Sutter Health
San Francisco 5391959, California 5332921 94109
United StatesActive - Recruiting
Kaiser San Francisco Medical Center
San Francisco 5391959, California 5332921 94118
United StatesSite Not Available
University of California San Francisco
San Francisco 5391959, California 5332921 94143
United StatesActive - Recruiting
Santa Barbara Cottage Hospital
Santa Barbara 5392952, California 5332921 93105
United StatesActive - Recruiting
Stanford Univeristy
Stanford 5398563, California 5332921 94305
United StatesActive - Recruiting
UC Health Medical Center of the Rockies
Loveland, Colorado 80538
United StatesSite Not Available
UC Health Medical Center of the Rockies
Loveland 5579368, Colorado 5417618 80538
United StatesActive - Recruiting
Yale Universtiy
New Haven, Connecticut 06510
United StatesSite Not Available
Yale Universtiy
New Haven 4839366, Connecticut 4831725 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 StatesSite Not Available
Sarasota Memorial Health Care System
Sarasota, Florida 34239
United StatesSite Not Available
The Cardiac & Vascular Institute Research Foundation
Gainesville 4156404, Florida 4155751 32605
United StatesSite Not Available
Baptist Health Research Center
Jacksonville 4160021, Florida 4155751 32207
United StatesActive - Recruiting
Sarasota Memorial Health Care System
Sarasota 4172131, Florida 4155751 34239
United StatesActive - Recruiting
Emory University Atlanta
Atlanta, Georgia 30308
United StatesSite Not Available
Piedmont Heart Institute
Atlanta, Georgia 30309
United StatesActive - Recruiting
Emory University Atlanta
Atlanta 4180439, Georgia 4197000 30308
United StatesActive - Recruiting
Piedmont Heart Institute
Atlanta 4180439, Georgia 4197000 30309
United StatesActive - Recruiting
Saint Alphonsus
Boise, Idaho 83704
United StatesSite Not Available
Saint Alphonsus
Boise 5586437, Idaho 5596512 83704
United StatesActive - Recruiting
Rush University Medical Center
Chicago, Illinois 60612
United StatesSite Not Available
Alexian Brothers Hospital
Lisle, Illinois 60532
United StatesSite Not Available
Rush University Medical Center
Chicago 4887398, Illinois 4896861 60612
United StatesSite Not Available
Alexian Brothers Hospital
Lisle 4900080, Illinois 4896861 60532
United StatesActive - Recruiting
Ascension Via Christi St. Francis
Wichita, Kansas 67226
United StatesSite Not Available
Cardiovascular Research Institute of Kansas
Wichita, Kansas 67226
United StatesActive - Recruiting
Ascension Via Christi St. Francis
Wichita 4281730, Kansas 4273857 67226
United StatesActive - Recruiting
Louisiana State University
New Orleans, Louisiana 70112
United StatesSite Not Available
Ochsner Clinical Foundation
New Orleans, Louisiana 70121
United StatesSite Not Available
Louisiana State University
New Orleans 4335045, Louisiana 4331987 70112
United StatesActive - Recruiting
Ochsner Clinical Foundation
New Orleans 4335045, Louisiana 4331987 70121
United StatesSite Not Available
Massachusetts General Hospital Boston
Boston, Massachusetts 02114
United StatesSite Not Available
Massachusetts General Hospital Boston
Boston 4930956, Massachusetts 6254926 02114
United StatesActive - Recruiting
Minneapolis Heart Institue, St. Paul's
Minneapolis, Minnesota 55102
United StatesSite Not Available
CentraCare Heart and Vascular Center
Saint Cloud, Minnesota 56303
United StatesSite Not Available
Minneapolis Heart Institue, St. Paul's
Minneapolis 5037649, Minnesota 5037779 55102
United StatesActive - Recruiting
CentraCare Heart and Vascular Center
Saint Cloud 5044407, Minnesota 5037779 56303
United StatesActive - Recruiting
Saint Luke's Hospital of Kansas City Mid America
Kansas City, Missouri 64111
United StatesSite Not Available
Saint Luke's Hospital of Kansas City Mid America
Kansas City 4393217, Missouri 4398678 64111
United StatesActive - Recruiting
St. Patrick Hospital
Missoula, Montana 59802
United StatesSite Not Available
St. Patrick Hospital
Missoula 5666639, Montana 5667009 59802
United StatesSite Not Available
Mary Hitchcock Memorial Hospital
Lebanon, New Hampshire 03756
United StatesSite Not Available
Mary Hitchcock Memorial Hospital
Lebanon 5088597, New Hampshire 5090174 03756
United StatesActive - Recruiting
Atlantic Health System Hospital Corp - Morristown Medical Center
Morristown, New Jersey 07960
United StatesSite Not Available
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 StatesSite Not Available
The Valley Hospital
Ridgewood, New Jersey 07450
United StatesSite Not Available
Atlantic Health System Hospital Corp - Morristown Medical Center
Morristown 5101427, New Jersey 5101760 07960
United StatesActive - Recruiting
Jersey Shore University Medical Center
Neptune City 5101687, New Jersey 5101760 07753
United StatesActive - Recruiting
Rutgers Robert Wood Johnson Medical School
New Brunswick 5101717, New Jersey 5101760 08901
United StatesActive - Recruiting
The Valley Hospital
Ridgewood 5103269, New Jersey 5101760 07450
United StatesActive - Recruiting
Montefiore Medical Center
Bronx, New York 10467
United StatesSite Not Available
University of Buffalo Kaleida Health
Buffalo, New York 14203
United StatesSite Not Available
NYU Langone Hospital - Long Island
Mineola, New York 11501
United StatesSite Not Available
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 StatesSite Not Available
St. Francis Hospital
Roslyn, New York 11576
United StatesSite Not Available
University of Buffalo Kaleida Health
Buffalo 5110629, New York 5128638 14203
United StatesActive - Recruiting
NYU Langone Hospital - Long Island
Mineola 5127134, New York 5128638 11501
United StatesActive - Recruiting
Columbia University Irving Medical Center/NYPH
New York 5128581, New York 5128638 10032
United StatesSite Not Available
NYU Langone Health
New York 5128581, New York 5128638 10016
United StatesSite Not Available
Rochester General Hospital
Rochester 5134086, New York 5128638 14621
United StatesActive - Recruiting
St. Francis Hospital
Roslyn 5134415, New York 5128638 11576
United StatesActive - Recruiting
Montefiore Medical Center
The Bronx 5110266, New York 5128638 10467
United StatesActive - Recruiting
Moses Cone Memorial Hospital
Greensboro, North Carolina 27401
United StatesSite Not Available
Moses Cone Memorial Hospital
Greensboro 4469146, North Carolina 4482348 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
The Christ Hospital
Cincinnati 4508722, Ohio 5165418 45219
United StatesSite Not Available
Mount Carmel Health System
Columbus 4509177, Ohio 5165418 43213
United StatesSite Not Available
Oklahoma Heart Institute
Tulsa, Oklahoma 74104
United StatesSite Not Available
Oklahoma Heart Institute
Tulsa 4553433, Oklahoma 4544379 74104
United StatesActive - Recruiting
Kaiser Permanente Northwest
Clackamas, Oregon 97015
United StatesSite Not Available
Legacy Emanuel Medical Center
Portland, Oregon 97227
United StatesSite Not Available
Providence Heart & Vascular Institute Portland
Portland, Oregon 97225
United StatesSite Not Available
Kaiser Permanente Northwest
Clackamas 5719308, Oregon 5744337 97015
United StatesSite Not Available
Legacy Emanuel Medical Center
Portland 5746545, Oregon 5744337 97227
United StatesActive - Recruiting
Providence Heart & Vascular Institute Portland
Portland 5746545, Oregon 5744337 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 StatesSite Not Available
Allegheny Singer Research Institute
Pittsburgh 5206379, Pennsylvania 6254927 15212
United StatesActive - Recruiting
UPMC Presbyterian Shadyside
Pittsburgh 5206379, Pennsylvania 6254927 15213
United StatesSite Not Available
Pinnacle Health Harrisburg
Wormleysburg 5220137, Pennsylvania 6254927 17043
United StatesSite Not Available
Lankenau Medical Center
Wynnewood 5220230, Pennsylvania 6254927 19096
United StatesActive - Recruiting
Baptist Memorial Hospital Memphis
Germantown, Tennessee 38138
United StatesSite Not Available
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 StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesActive - Recruiting
Baptist Memorial Hospital Memphis
Germantown 4624601, Tennessee 4662168 38138
United StatesActive - Recruiting
Methodist Le Bonheur Healthcare
Germantown 4624601, Tennessee 4662168 38138
United StatesActive - Recruiting
Parkwest Medical Center
Knoxville 4634946, Tennessee 4662168 37923
United StatesActive - Recruiting
Saint Thomas Health
Nashville 4644585, Tennessee 4662168 37205
United StatesActive - Recruiting
Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37232
United StatesActive - Recruiting
Ascension Texas Cardiovascular
Austin, Texas 78705
United StatesSite Not Available
UT Southwestern Medical Center
Dallas, Texas 75235
United StatesSite Not Available
HCA Houston Healthcare Medical Center
Houston, Texas 77004
United StatesSite Not Available
The University of Texas Health Science Center
Houston, Texas 77030
United StatesActive - Recruiting
The Heart Hospital Baylor Plano
Plano, Texas 75093
United StatesSite Not Available
Methodist Hospital of San Antonio
San Antonio, Texas 78229
United StatesSite Not Available
Ascension Texas Cardiovascular
Austin 4671654, Texas 4736286 78705
United StatesActive - Recruiting
UT Southwestern Medical Center
Dallas 4684888, Texas 4736286 75235
United StatesActive - Recruiting
HCA Houston Healthcare Medical Center
Houston 4699066, Texas 4736286 77004
United StatesActive - Recruiting
The University of Texas Health Science Center
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
The Heart Hospital Baylor Plano
Plano 4719457, Texas 4736286 75093
United StatesActive - Recruiting
Methodist Hospital of San Antonio
San Antonio 4726206, Texas 4736286 78229
United StatesSite Not Available
Kaiser Mid Atlantic
McLean, Virginia 22102
United StatesSite Not Available
Sentara Norfolk General Hospital
Norfolk, Virginia 23507
United StatesSite Not Available
Kaiser Mid Atlantic
McLean 4772354, Virginia 6254928 22102
United StatesActive - Recruiting
Sentara Norfolk General Hospital
Norfolk 4776222, Virginia 6254928 23507
United StatesActive - Recruiting
Swedish Medical Center
Seattle, Washington 98112
United StatesSite Not Available
Swedish Medical Center
Seattle 5809844, Washington 5815135 98112
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.