NCT02698956

SOURCE 3: Observational Study to Evaluate Safety and Performance of SAPIEN 3 THV System in Real Life Practice

Edwards SAPIEN 3 Aortic Bioprosthesis Multi-Region Outcome Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
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 ≥15

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-02-01
• Completion: 2020-11-30
• First posted: 2016-03-04
• Last updated: 2021-03-16

Locations

73 sites across 10 countries: Denmark, Finland, France, Germany, Italy, Netherlands, Slovakia, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study