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NCT03104660 Clinical Trial

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

Mitral Valve Regurgitation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03104660
Other study ID # CSI-Ulm-TMVR
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 15, 2017
Est. completion date December 31, 2018

Study information
Verified date April 2020
Source University of Ulm
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 355
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- mitral valve regurgitation

- transcatheter mitral valve repair

Exclusion Criteria:

- no written informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• CE certified mitral valve repair systems
Patients receive a transcatheter mitral valve repair with CE certified transcatheter mitral repair systems.

Locations
Country Name City State
Germany University Hospital Ulm Ulm

Sponsors (1)
Lead Sponsor Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Seeger J, Markovic S, Kessler M, Rottbauer W, Wöhrle J. Apixaban After Percutaneous Edge-to-Edge Mitral Valve Repair in Patients With Maintained Sinus Rhythm. JACC Cardiovasc Interv. 2019 Jan 28;12(2):214-216. doi: 10.1016/j.jcin.2018.11.009. — View Citation

Seeger J, Müller P, Gonska B, Scharnbeck D, Markovic S, Walcher D, Rottbauer W, Wöhrle J. Percutaneous Mitral Valve Repair With the MitraClip in Primary Compared With Secondary Mitral Valve Regurgitation Using the Mitral Valve Academic Research Consortium — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Major adverse cerebral and cardiac events Major adverse cerebral and cardiac events 10 years
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