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

Completed

• Conditions: Aortic Stenosis

• Registration Number: NCT02698956
• Lead Sponsor: Edwards Lifesciences

Brief 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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2015-02-27
• Primary Completion: 2016-02
• Study First Submitted QC: 2016-02-29
• Study First Posted: 2016-03-04
• Study Completion: 2020-11-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-12
• Last Update Posted: 2021-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Patient suffering from severe, symptomatic, calcific aortic stenosis
• STS Score ≥ 8
• Logistic EuroSCORE ≥15

Exclusion Criteria

• Congenital unicuspid or congenital bicuspid aortic valve
• Evidence of intracardiac mass, thrombus or vegetation
• Active infection or endocarditis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All cause mortality	30 days

Trial Locations

Locations (73)

Aarhus University Hospital, Skejby; 🇩🇰 Aarhus, Denmark

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Oulu University Hospital; 🇫🇮 Oulu, Finland

CHU Angers; 🇫🇷 Angers, France

Hopital Jean Minjoz - Besancon; 🇫🇷 Besancon, France

Clinique Saint-Augustin - Bordeaux; 🇫🇷 Bordeaux, France

CHU La Cavalle Blanche - Brest; 🇫🇷 Brest, France

CHU Gabriel-Montpied - Clermont Ferrand; 🇫🇷 Clermont Ferrand, France

CHU Bocage - Dijon; 🇫🇷 Dijon, France

Centre Hospitalier Universitaire de Grenoble; 🇫🇷 Grenoble, France

Scroll for more (63 remaining)