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 : March 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Aortic Stenosis Heart Diseases||Device: Edwards SAPIEN 3 / SAPIEN 3 Ultra 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 / 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
- 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: John Tejeda||John_Tejeda@edwards.com|
|Principal Investigator:||Philippe Généreux, MD||Gagnon Cardiovascular Institute - Morristown Medical Center, Cardiovascular Research Foundation|