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CENTERA PMCF: Post-Market Follow-up of the CENTERA Transcatheter Heart Valve System

NCT03699345 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 87

Last updated 2024-11-04

No results posted yet for this study

Summary

This study will monitor device performance and safety of the Edwards CENTERA Transcatheter Heart Valve (THV) system in patients with severe, symptomatic aortic valve stenosis who are indicated for aortic valve replacement.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

Transcatheter Aortic Valve Replacement (TAVR)

TAVR with the Edwards CENTERA THV System and accessories

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Prof. Hermann Reichenspurner · UKE Hamburg-Eppendorf - University Heart Center

  • Prof.Dr. Stephan Windecker · Inselspital, Klinik für Kardiologie

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-07
Primary Completion
2019-08-14
Completion
2024-08-20
FDA Device
Yes

Countries

  • Denmark
  • France
  • Germany
  • Netherlands
  • Spain
  • 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 NCT03699345 on ClinicalTrials.gov