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Trial record 9 of 10 for:    Baylor | severe aortic stenosis

Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis (EARLY TAVR)

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ClinicalTrials.gov Identifier: NCT03042104
Recruitment Status : Recruiting
First Posted : February 3, 2017
Last Update Posted : December 22, 2017
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:
This clinical trial is a prospective, randomized, controlled, multi-center study. Patients will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 THV or clinical surveillance. Patients will be stratified by whether or not they are able to perform a treadmill stress test. Patients who have a positive stress test will be followed in a registry to collect data on subsequent treatment and mortality, as applicable.

Condition or disease Intervention/treatment
Aortic Stenosis Heart Diseases Device: Edwards SAPIEN 3 THV

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis
Actual Study Start Date : July 12, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2031

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: TAVR
Transcatheter aortic valve replacement (TAVR) arm will have intervention with the Edwards SAPIEN 3 THV.
Device: Edwards SAPIEN 3 THV
Patients in experimental arm will receive SAPIEN 3 THV.
Other Name: SAPIEN 3
No Intervention: CS
Clinical surveillance

Primary Outcome Measures :
  1. Non-hierarchical composite endpoint of all-cause death, all stroke, and unplanned cardiovascular hospitalization. [ Time Frame: 2 years ]
    This measure is a non-hierarchical composite of any of the following events: all-cause death or stroke or unplanned cardiovascular hospitalization. For the analysis, the trial arms will be compared using the log-rank test at α=0.05.

Secondary Outcome Measures :
  1. Death or disabling stroke [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Severe aortic stenosis
  2. Patient is asymptomatic
  3. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the institutional review board of the respective clinical site.

Exclusion Criteria:

  1. Patient is symptomatic.
  2. Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath.
  3. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.
  4. Aortic valve is a unicuspid, bicuspid, or is non-calcified.
  5. Severe aortic regurgitation (>3+).
  6. Severe mitral regurgitation (>3+) or ≥ moderate mitral stenosis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03042104

Contact: Elizabeth Lau, PhD 949-250-3592 Elizabeth_Lau@edwards.com
Contact: Tenley Koepnick Tenley_Koepnick@edwards.com

  Hide Study Locations
United States, California
Mills Peninsula Health Services Recruiting
Burlingame, California, United States, 94010
Hoag Memorial Hospital Presbyterian Recruiting
Newport Beach, California, United States, 92663
Stanford Hospital and Clinics Palo Alto Recruiting
Stanford, California, United States, 94305
United States, Colorado
UC Health Northern Colorado (Medical Center of the Rockies) Recruiting
Loveland, Colorado, United States, 80538
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
United States, District of Columbia
Washington Hospital Center DC Recruiting
Washington, District of Columbia, United States, 20010
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Rush University Medical Center Chicago Recruiting
Chicago, Illinois, United States, 60612
NorthShore University HealthSystem Research Institution Evanston Recruiting
Evanston, Illinois, United States, 60201
Prairie Education and Research Cooperative Recruiting
Springfield, Illinois, United States, 62701
United States, Kansas
Cardiovascular Research Institute of Kansas Recruiting
Wichita, Kansas, United States, 67226
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Atlantic Health System Hospital Corp - Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07960
Newark Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 07112
United States, New York
Winthrop University Hospital Mineola Recruiting
Mineola, New York, United States, 11501
New York University Langone Medical Center Recruiting
New York, New York, United States, 10016
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Cornell University Recruiting
New York, New York, United States, 10065
United States, North Carolina
Carolina's Health System Recruiting
Charlotte, North Carolina, United States, 28203
NC Heart and Vascular (Rex Hospital) Recruiting
Raleigh, North Carolina, United States, 27607
United States, Ohio
The Christ Hospital, Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
Mount Carmel Health System Recruiting
Columbus, Ohio, United States, 43213
United States, Oklahoma
Oklahoma Cardiovascular Research Group Recruiting
Oklahoma City, Oklahoma, United States, 73120
United States, Pennsylvania
Pinnacle Health Recruiting
Harrisburg, Pennsylvania, United States, 17101
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Lankenau Medical Center Recruiting
Wynnewood, Pennsylvania, United States, 19096
York Hospital Recruiting
York, Pennsylvania, United States, 17403
United States, Texas
The Heart Hospital Baylor Plano Recruiting
Dallas, Texas, United States, 75093
University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
United States, Utah
Intermountain Medical Center Salt Lake City Recruiting
Murray, Utah, United States, 84107
United States, Virginia
Inova Heart and Vascular Institute (Fairfax Inova) Recruiting
Falls Church, Virginia, United States, 22042
Sentara Cardiovascular Research Institute Recruiting
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Edwards Lifesciences
Principal Investigator: Philippe Généreux, MD Gagnon Cardiovascular Institute - Morristown Medical Center, Cardiovascular Research Foundation

Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT03042104     History of Changes
Other Study ID Numbers: 2016-07
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Edwards Lifesciences:
Heart Disease
Aortic Valve

Additional relevant MeSH terms:
Heart Diseases
Constriction, Pathologic
Aortic Valve Stenosis
Cardiovascular Diseases
Pathological Conditions, Anatomical
Heart Valve Diseases
Ventricular Outflow Obstruction