Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation

NCT04818502 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2024-06-12

No results posted yet for this study

Summary

To evaluate the safety and performance of the Tendyne™ Mitral Valve System when used as intended in a contemporary, real-world setting.

Conditions

  • Mitral Valve Regurgitation

Interventions

DEVICE

Tendyne™ Mitral Valve System

Transcatheter mitral valve implantation (TMVI) using the Tendyne™ Mitral Valve System , in which a bioprosthetic valve is implanted within the native mitral valve.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-04
Primary Completion
2025-05-31
Completion
2029-05-31

Countries

  • Austria
  • Belgium
  • Czechia
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Norway
  • Saudi Arabia
  • 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 NCT04818502 on ClinicalTrials.gov