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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 : September 18, 2020
Sponsor:
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 / 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.

Condition or disease Intervention/treatment Phase
Aortic Stenosis Heart Diseases Device: Edwards SAPIEN 3 / SAPIEN 3 Ultra THV Not Applicable

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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


Arm Intervention/treatment
Experimental: TAVR
Transcatheter aortic valve replacement (TAVR) arm will have intervention with the Edwards SAPIEN 3 / SAPIEN 3 Ultra THV.
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

No Intervention: CS
Clinical surveillance



Primary Outcome Measures :
  1. 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.


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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.

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


Contacts
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Contact: Elizabeth Lau, PhD 949-250-3592 Elizabeth_Lau@edwards.com
Contact: John Tejeda John_Tejeda@edwards.com

Locations
Show Show 84 study locations
Sponsors and Collaborators
Edwards Lifesciences
Investigators
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Principal Investigator: Philippe Généreux, MD Gagnon Cardiovascular Institute - Morristown Medical Center, Cardiovascular Research Foundation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT03042104    
Other Study ID Numbers: 2016-07
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Edwards Lifesciences:
Stenosis
Heart Disease
Valve
Tricuspid
Aortic Valve
Asymptomatic
Additional relevant MeSH terms:
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Heart Diseases
Aortic Valve Stenosis
Constriction, Pathologic
Cardiovascular Diseases
Pathological Conditions, Anatomical
Heart Valve Diseases
Ventricular Outflow Obstruction