MitraClip® Registry
1 other identifier
observational
200
1 country
1
Brief Summary
Percutaneous mitral valve repair with the MitraClip® system has emerged as a therapeutic alternative to surgical valve repair (PMVR) in high risk patients. The aim of this registry is to collect prospectively and systematically clinical research data from patients undergoing PMVR with the MitraClip® system. This registry is an open-end observational study to assess the characteristics and outcomes patients with severe mitral regurgitation undergoing PMVR.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 9, 2014
CompletedFirst Posted
Study publicly available on registry
January 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
February 7, 2020
February 1, 2020
16.9 years
January 9, 2014
February 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major cardiac adverse events
increase in the 30-day risk of adverse events among patients receiving PMVR
30 days
Secondary Outcomes (1)
Mortality
1 year
Eligibility Criteria
Patients undergoing percutaneous mitral valve repair (PMVR) with the MitraClip® system
You may qualify if:
- severe mitral regurgitation
- percutaneous mitral valve repair (PMVR) with the MitraClip® system
You may not qualify if:
- \< 18 years
- Patients considered by the heart team to be unlikely to receive meaningful or durable clinical benefit from the procedure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Heinrich Heine University Div. of Cardiology, Pulmonary Disease and Vasculae Medicine
Düsseldorf, 40225, Germany
Related Publications (3)
Herbrand T, Eschenhagen S, Zeus T, Kehmeier E, Hellhammer K, Veulemans V, Kelm M, Balzer J. Acute reverse annular remodeling during MitraClip(R) therapy predicts improved clinical outcome in heart failure patients: a 3D echocardiography study. Eur J Med Res. 2017 Sep 20;22(1):33. doi: 10.1186/s40001-017-0273-x.
PMID: 28931437DERIVEDRammos C, Zeus T, Balzer J, Veulemans V, Hellhammer K, Niebel S, Kelm M, Rassaf T. Left Atrial and Left Ventricular Function and Remodeling Following Percutaneous Mitral Valve Repair. J Heart Valve Dis. 2016 May;25(3):309-319.
PMID: 27989041DERIVEDHellhammer K, Zeus T, Balzer J, van Hall S, Rammos C, Wagstaff R, Kelm M, Rassaf T. Safety and efficacy of percutaneous mitral valve repair using the MitraClip(R) system in patients with diabetes mellitus. PLoS One. 2014 Nov 6;9(11):e111178. doi: 10.1371/journal.pone.0111178. eCollection 2014.
PMID: 25375257DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Malte Kelm, MD
Division of Cardiology, Pulmonary Disease and Vascular Medicine
- STUDY CHAIR
Malte Kelm, MD
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director Division of Cardiology, Pulmonary Disease and Vascular Medicine
Study Record Dates
First Submitted
January 9, 2014
First Posted
January 13, 2014
Study Start
January 1, 2014
Primary Completion (Estimated)
December 1, 2030
Study Completion (Estimated)
December 1, 2030
Last Updated
February 7, 2020
Record last verified: 2020-02