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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03042104
Recruitment Status : Recruiting
First Posted : February 3, 2017
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Tracking Information
First Submitted Date  ICMJE January 30, 2017
First Posted Date  ICMJE February 3, 2017
Last Update Posted Date April 7, 2020
Actual Study Start Date  ICMJE July 12, 2017
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 1, 2017)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2017)
Death or disabling stroke [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis
Official Title  ICMJE Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis
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 / SAPIEN 3 Ultra 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Aortic Stenosis
  • Heart Diseases
Intervention  ICMJE Device: Edwards SAPIEN 3 / SAPIEN 3 Ultra THV
Patients in experimental arm will receive SAPIEN 3 / SAPIEN 3 Ultra THV.
Other Name: SAPIEN 3, SAPIEN 3 Ultra
Study Arms  ICMJE
  • Experimental: TAVR
    Transcatheter aortic valve replacement (TAVR) arm will have intervention with the Edwards SAPIEN 3 / SAPIEN 3 Ultra THV.
    Intervention: Device: Edwards SAPIEN 3 / SAPIEN 3 Ultra THV
  • No Intervention: CS
    Clinical surveillance
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 1, 2017)
1109
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2031
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 with unfavorable features for TAVR or is non-calcified.
  5. Severe aortic regurgitation (>3+).
  6. Severe mitral regurgitation (>3+) or ≥ moderate mitral stenosis.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Elizabeth Lau, PhD 949-250-3592 Elizabeth_Lau@edwards.com
Contact: John Tejeda John_Tejeda@edwards.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03042104
Other Study ID Numbers  ICMJE 2016-07
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Edwards Lifesciences
Study Sponsor  ICMJE Edwards Lifesciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philippe Généreux, MD Gagnon Cardiovascular Institute - Morristown Medical Center, Cardiovascular Research Foundation
PRS Account Edwards Lifesciences
Verification Date April 2020

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