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

NCT02698956 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2021-03-16

No results posted yet for this study

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.

Conditions

  • Aortic Stenosis

Interventions

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

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Prof. Dr. Olaf Wendler, MD · King's College Hospital NHS Trust

  • Prof. Dr. Alec Vahanian, MD · Hopital Bichat, Paris

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-02-29
Completion
2020-11-30
FDA Device
Yes

Countries

  • Denmark
  • Finland
  • France
  • Germany
  • Italy
  • Netherlands
  • Slovakia
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02698956 on ClinicalTrials.gov