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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 4068590, Alabama 4829764 35801

Cedars-Sinai Medical Center
Los Angeles 5368361, California 5332921 90048

Eisenhower Desert Cardiology Center
Rancho Mirage 5386015, California 5332921 92270

Bay Area Structural Heart at Sutter Health
San Francisco 5391959, California 5332921 94109

University of California San Francisco
San Francisco 5391959, California 5332921 94143

Santa Barbara Cottage Hospital
Santa Barbara 5392952, California 5332921 93105

Stanford Univeristy
Stanford 5398563, California 5332921 94305

UC Health Medical Center of the Rockies
Loveland 5579368, Colorado 5417618 80538

Yale Universtiy
New Haven 4839366, Connecticut 4831725 06510

Baptist Health Research Center
Jacksonville 4160021, Florida 4155751 32207

Sarasota Memorial Health Care System
Sarasota 4172131, Florida 4155751 34239

Emory University Atlanta
Atlanta 4180439, Georgia 4197000 30308

Piedmont Heart Institute
Atlanta 4180439, Georgia 4197000 30309

Saint Alphonsus
Boise 5586437, Idaho 5596512 83704

Rush University Medical Center
Chicago 4887398, Illinois 4896861 60612

Alexian Brothers Hospital
Lisle 4900080, Illinois 4896861 60532

Ascension Via Christi St. Francis
Wichita 4281730, Kansas 4273857 67226

Louisiana State University
New Orleans 4335045, Louisiana 4331987 70112

Massachusetts General Hospital Boston
Boston 4930956, Massachusetts 6254926 02114

Minneapolis Heart Institue, St. Paul's
Minneapolis 5037649, Minnesota 5037779 55102

CentraCare Heart and Vascular Center
Saint Cloud 5044407, Minnesota 5037779 56303

Saint Luke's Hospital of Kansas City Mid America
Kansas City 4393217, Missouri 4398678 64111

Mary Hitchcock Memorial Hospital
Lebanon 5088597, New Hampshire 5090174 03756

Atlantic Health System Hospital Corp - Morristown Medical Center
Morristown 5101427, New Jersey 5101760 07960

Jersey Shore University Medical Center
Neptune City 5101687, New Jersey 5101760 07753

Rutgers Robert Wood Johnson Medical School
New Brunswick 5101717, New Jersey 5101760 08901

The Valley Hospital
Ridgewood 5103269, New Jersey 5101760 07450

University of Buffalo Kaleida Health
Buffalo 5110629, New York 5128638 14203

NYU Langone Hospital - Long Island
Mineola 5127134, New York 5128638 11501

Rochester General Hospital
Rochester 5134086, New York 5128638 14621

St. Francis Hospital
Roslyn 5134415, New York 5128638 11576

Montefiore Medical Center
The Bronx 5110266, New York 5128638 10467

Moses Cone Memorial Hospital
Greensboro 4469146, North Carolina 4482348 27401

Oklahoma Heart Institute
Tulsa 4553433, Oklahoma 4544379 74104

Legacy Emanuel Medical Center
Portland 5746545, Oregon 5744337 97227

Allegheny Singer Research Institute
Pittsburgh 5206379, Pennsylvania 6254927 15212

Lankenau Medical Center
Wynnewood 5220230, Pennsylvania 6254927 19096

Baptist Memorial Hospital Memphis
Germantown 4624601, Tennessee 4662168 38138

Methodist Le Bonheur Healthcare
Germantown 4624601, Tennessee 4662168 38138

Parkwest Medical Center
Knoxville 4634946, Tennessee 4662168 37923

Saint Thomas Health
Nashville 4644585, Tennessee 4662168 37205

Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37232

Ascension Texas Cardiovascular
Austin 4671654, Texas 4736286 78705

UT Southwestern Medical Center
Dallas 4684888, Texas 4736286 75235

HCA Houston Healthcare Medical Center
Houston 4699066, Texas 4736286 77004

The University of Texas Health Science Center
Houston 4699066, Texas 4736286 77030

The Heart Hospital Baylor Plano
Plano 4719457, Texas 4736286 75093

Kaiser Mid Atlantic
McLean 4772354, Virginia 6254928 22102

Sentara Norfolk General Hospital
Norfolk 4776222, Virginia 6254928 23507

Swedish Medical Center
Seattle 5809844, Washington 5815135 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.