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Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve/ The SAPIEN 3 Study

NCT01808287 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2020-04-01

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and device success of the Edwards SAPIEN 3 Transcatheter Heart Valve (S3 THV) and the Edwards Commander and Certitude Delivery Systems in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.

Conditions

  • Aortic Valve Disease

Interventions

DEVICE

Edwards SAPIEN 3 Transcatheter Heart Valve

The Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System is indicated for use in symptomatic patients (intermediate or higher operable risk) with severe aortic stenosis requiring aortic valve replacement (AVR).

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • John Webb, MD · St. Paul's Hospital Vancouver (Canada)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-12-31
Completion
2019-12-17

Countries

  • Canada
  • France
  • Germany
  • Italy
  • 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 NCT01808287 on ClinicalTrials.gov