SOURCE 3: Observational Study to Evaluate Safety and Performance of SAPIEN 3 THV System in Real Life Practice
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Volunteers
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
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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