Observational Study to Evaluate Safety and Performance of SAPIEN 3 THV System in Real Life Practice. (SOURCE 3)
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|ClinicalTrials.gov Identifier: NCT02698956|
Recruitment Status : Active, not recruiting
First Posted : March 4, 2016
Last Update Posted : October 5, 2020
This is an international, mutli-center, prospective, consecutively enrolled, observational registry. 2000 patients are planned to be enrolled over one year at up to 150 participating sites.
300 patients out of the 2000 patients enrolled in the main registry are planned to be consecutively enrolled in a select few sites for studying the valve performance. Echocardiogram and angiogram will be taken routinely.
|Condition or disease||Intervention/treatment|
|Aortic Stenosis||Device: TAVI (Transcatheter Aortic Valve Implantation)|
The purpose of this registry is to provide clinical outcome and safety information on patients that will be treated with the Edwards SAPIEN 3 Transcatheter Heart Valve and delivery devices for severe, symptomatic calcific aortic stenosis. In addition, the information collected will serve post market safety and surveillance regulatory obligations.
Consecutive patient data will be collected at baseline, procedure, discharge, after discharge (at approx. 30 days post-index procedure), 12 months post-index procedure and annually thereafter up to 5 years post-implant according to usual practice at site.
|Study Type :||Observational|
|Actual Enrollment :||2000 participants|
|Official Title:||Edwards SAPIEN 3 Aortic Bioprosthesis Multi-Region Outcome Registry.|
|Actual Study Start Date :||July 2014|
|Actual Primary Completion Date :||February 2016|
|Estimated Study Completion Date :||December 2020|
- Device: TAVI (Transcatheter Aortic Valve Implantation)
Edwards SAPIEN 3 Transcatheter Heart Valve (S3 THV) and Edwards Commander Delivery system (transfemoral) and Certitude Delivery system (transapical/transaortic). The Edwards S3 THV is indicated for use in patients with severe, symptomatic, calcific aortic stenosis with STS Score ≥ 8 or Logistic EuroSCORE ≥15Other Name: TAVR
- All cause mortality [ Time Frame: 30 days ]
- New York Heart Association Functional Classification [ Time Frame: 30 days ]
- Cardiovascular mortality (including any valve-related dysfunction or any valve-related adverse event [ Time Frame: 30 days ]
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): NCT02698956
|Principal Investigator:||Prof. Dr. Olaf Wendler, MD||King's College Hospital, London|
|Principal Investigator:||Prof. Dr. Alec Vahanian, MD||Hopital Bichat, Paris|