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 : September 16, 2019

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Sponsor:

Information provided by (Responsible Party):

Edwards Lifesciences

Study Description

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	Phase
Aortic Stenosis Heart Diseases	Device: Edwards SAPIEN 3 THV	Not Applicable

Study Design

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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

Genetics Home Reference related topics: Supravalvular aortic stenosis

Genetic and Rare Diseases Information Center resources: Aortic Valve Stenosis

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 :

Death or disabling stroke [ Time Frame: 2 years ]

Eligibility Criteria

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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:

Severe aortic stenosis
Patient is asymptomatic
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:

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

Contacts and Locations

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

Show 72 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

More Information

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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:	September 16, 2019
Last Verified:	September 2019
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
Device Product Not Approved or Cleared by U.S. FDA:	No
Pediatric Postmarket Surveillance of a Device Product:	No

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

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