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Safety and Performance Study of the Edwards CENTERA Self-Expanding Transcatheter Heart Valve

NCT01808274 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2018-11-20

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.

Conditions

  • Aortic Valve Disease

Interventions

DEVICE

Edwards CENTERA Self-Expanding Transcatheter Heart Valve

The Edwards CENTERA Transcatheter Heart Valve (THV) System is indicated for use in symptomatic patients (high surgical risk) with severe aortic stenosis requiring aortic valve replacement (AVR).

Sponsors & Collaborators

  • Medstar Health Research Institute

    collaborator OTHER

  • European Cardiovascular Research Center

    collaborator NETWORK

  • University of British Columbia

    collaborator OTHER

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Prof. Windecker, MD · Inselspital Bern (Switzerland)

  • Prof. Mohr, MD · Leipzig, Rhön Herzentrum (Germany)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-01
Primary Completion
2013-09-17
Completion
2018-08-23

Countries

  • Germany
  • Switzerland

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 NCT01808274 on ClinicalTrials.gov