Coronary and Structural Interventions Ulm - Transcatheter Mitral Valve Repair (CSI-Ulm-TMVR)

Not Applicable

Completed

• Conditions: Mitral Valve Regurgitation
• Interventions: Device: CE certified mitral valve repair systems

• Registration Number: NCT03104660
• Lead Sponsor: University of Ulm

Brief Summary

To evaluate the long-term results after transcatheter mitral valve repair

Detailed Description

Patients with transcatheter mitral valve repair are followed for 10 years to demonstrate efficacy and safety.

Study Timeline

• Study Start: 2017-03-15
• Study First Submitted: 2017-04-03
• Study First Submitted QC: 2017-04-03
• Study First Posted: 2017-04-07
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-25
• Last Update Posted: 2020-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 355

Inclusion Criteria

• mitral valve regurgitation
• transcatheter mitral valve repair

Exclusion Criteria

• no written informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CE certified mitral valve repair systems	CE certified mitral valve repair systems	CE certified transcatheter mitral valve repair systems

Primary Outcome Measures

Name	Time	Method
Major adverse cerebral and cardiac events	10 years	Major adverse cerebral and cardiac events

Trial Locations

Locations (1)

University Hospital Ulm; 🇩🇪 Ulm, Germany