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Clinical Trials/NCT04009434
NCT04009434
Unknown
Not Applicable

Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation

Technische Universität Dresden1 site in 1 country1,162 target enrollmentDecember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aortic Stenosis
Sponsor
Technische Universität Dresden
Enrollment
1162
Locations
1
Primary Endpoint
Death from any cause and heart failure hospitalization
Last Updated
6 years ago

Overview

Brief Summary

To evaluate whether patients after successful transfemoral transcatheter aortic valve implantation (TAVI), who have concomitant, moderate to severe mitral regurgitation (MR) benefit from an additional treatment of this valve disease as well.

Registry
clinicaltrials.gov
Start Date
December 1, 2019
End Date
August 1, 2023
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Death from any cause and heart failure hospitalization

Time Frame: 1 year

Composite endpoint of time to heart failure hospitalization or death from any cause

Secondary Outcomes

  • 6 Minute Walk Test(1 year)
  • Death from any cause(1, 2, 3, 4 years)
  • Need for mitral valve reintervention(1, 2, 3, 4 years)
  • Mitral regurgitation severity(1 year)
  • New York Heart Association Functional Class(1, 3, 6 months and 1, 2, 3, 4 years)

Study Sites (1)

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