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

NCT04009434 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1162

Last updated 2020-02-05

No results posted yet for this study

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.

Conditions

  • Aortic Stenosis
  • Mitral Regurgitation

Interventions

DEVICE

Mitral Valve Clipping

Patients receive treatment for mitral regurgitation with mitral valve clipping including standard drug therapy.

DEVICE

TAVI

Transfemoral transcatheter aortic valve implantation plus optimal standard of care therapy.

Sponsors & Collaborators

  • Zentrum für Klinische Studien Leipzig

    collaborator OTHER

  • University Medical Center Mainz

    collaborator OTHER

  • Technische Universität Dresden

    lead OTHER

Principal Investigators

  • Axel Linke, MD · Technische Universitaet Dresden, HEART CENTER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2023-08-01
Completion
2023-08-01

Countries

  • Germany

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 NCT04009434 on ClinicalTrials.gov