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 : April 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Aortic Stenosis Heart Diseases||Device: Edwards SAPIEN 3 THV||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1109 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- Death or disabling stroke [ Time Frame: 2 years ]
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|
Show 37 Study Locations
|Principal Investigator:||Philippe Généreux, MD||Gagnon Cardiovascular Institute - Morristown Medical Center, Cardiovascular Research Foundation|