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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 : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

January 30, 2017
February 3, 2017
May 3, 2018
July 12, 2017
December 2021   (Final data collection date for primary outcome measure)
Freedom from a non-hierarchical composite endpoint of all-cause death, all stroke, and unplanned cardiovascular hospitalization. [ Time Frame: 2 years ]
For the analysis, the trial arms will be compared using the log-rank test.
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.
Complete list of historical versions of study NCT03042104 on ClinicalTrials.gov Archive Site
Death or disabling stroke [ Time Frame: 2 years ]
Same as current
Not Provided
Not Provided
 
Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis
Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Aortic Stenosis
  • Heart Diseases
Device: Edwards SAPIEN 3 THV
Patients in experimental arm will receive SAPIEN 3 THV.
Other Name: SAPIEN 3
  • Experimental: TAVR
    Transcatheter aortic valve replacement (TAVR) arm will have intervention with the Edwards SAPIEN 3 THV.
    Intervention: Device: Edwards SAPIEN 3 THV
  • No Intervention: CS
    Clinical surveillance
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1109
Same as current
December 2031
December 2021   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
65 Years and older   (Older Adult)
No
Contact: Elizabeth Lau, PhD 949-250-3592 Elizabeth_Lau@edwards.com
Contact: Tenley Koepnick Tenley_Koepnick@edwards.com
United States
 
 
NCT03042104
2016-07
Yes
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
Plan to Share IPD: No
Edwards Lifesciences
Edwards Lifesciences
Not Provided
Principal Investigator: Philippe Généreux, MD Gagnon Cardiovascular Institute - Morristown Medical Center, Cardiovascular Research Foundation
Edwards Lifesciences
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP