Back to resultsCoronary and Structural Interventions Ulm - Transcatheter Mitral Valve Repair (CSI-Ulm-TMVR)
Primary Purpose
Mitral Valve Regurgitation
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
CE certified mitral valve repair systems
Sponsored by
About this trial
This is an interventional treatment trial for Mitral Valve Regurgitation
Eligibility Criteria
Inclusion Criteria:
- mitral valve regurgitation
- transcatheter mitral valve repair
Exclusion Criteria:
- no written informed consent
Sites / Locations
- University Hospital Ulm
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CE certified mitral valve repair systems
Arm Description
CE certified transcatheter mitral valve repair systems
Outcomes
Primary Outcome Measures
Major adverse cerebral and cardiac events
Major adverse cerebral and cardiac events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03104660
Brief Title
Coronary and Structural Interventions Ulm - Transcatheter Mitral Valve Repair (CSI-Ulm-TMVR)
Official Title
Coronary and Structural Interventions Ulm - Transcatheter Mitral Valve Repair (CSI-Ulm-TMVR)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 15, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ulm
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Regurgitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
CE certified mitral valve repair systems
Masking
None (Open Label)
Allocation
N/A
Enrollment
355 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CE certified mitral valve repair systems
Arm Type
Experimental
Arm Description
CE certified transcatheter mitral valve repair systems
Intervention Type
Device
Intervention Name(s)
CE certified mitral valve repair systems
Intervention Description
Patients receive a transcatheter mitral valve repair with CE certified transcatheter mitral repair systems.
Primary Outcome Measure Information:
Title
Major adverse cerebral and cardiac events
Description
Major adverse cerebral and cardiac events
Time Frame
10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
mitral valve regurgitation
transcatheter mitral valve repair
Exclusion Criteria:
no written informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jochen Woehrle, MD
Organizational Affiliation
University Hospital Ulm
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30678801
Citation
Seeger J, Markovic S, Kessler M, Rottbauer W, Wohrle 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. No abstract available.
Results Reference
result
PubMed Identifier
28368846
Citation
Seeger J, Muller P, Gonska B, Scharnbeck D, Markovic S, Walcher D, Rottbauer W, Wohrle J. Percutaneous Mitral Valve Repair With the MitraClip in Primary Compared With Secondary Mitral Valve Regurgitation Using the Mitral Valve Academic Research Consortium Criteria. J Invasive Cardiol. 2017 Apr;29(4):145-150.
Results Reference
result
Learn more about this trial
Coronary and Structural Interventions Ulm - Transcatheter Mitral Valve Repair (CSI-Ulm-TMVR)
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