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CENTERA-2: Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve

NCT02458560 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 203

Last updated 2021-10-18

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 symptomatic adult patients with severe aortic stenosis.

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. Hermann Reichenspurner, MD · University Heart Center Hamburg (Germany)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-08-22
Completion
2021-08-13
FDA Device
Yes

Countries

  • Australia
  • Denmark
  • France
  • Germany
  • Italy
  • Netherlands
  • New Zealand
  • 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 NCT02458560 on ClinicalTrials.gov