MitraClip® After Surgical Mitral Valve Repair

• Conditions: Mitral Regurgitation

• Registration Number: NCT02853955
• Lead Sponsor: LMU Klinikum

Brief Summary

Percutaneous edge-to-edge repair of the mitral valve has been shown to be a safe and effective alternative treatment option for selected patients at high risk for cardiac surgery. Patients with recurrent mitral regurgitation after surgical mitral valve repair (sMVR) are per se at increased risk for another cardiac surgery. The purpose of this multicenter retrospective analysis of patients treated with a MitraClip® after sMVR, is to evaluate the effectiveness and durability of this minimally invasive treatment option in this subset of patients.

Detailed Description

In this multicenter retrospective analysis of MitraClip® cases after MVR the effectiveness and durability of this minimally invasive treatment option in this subset of patients will be evaluated.

Study Timeline

• Study First Submitted: 2016-03-31
• Study Start: 2016-05
• Status Verified: 2016-07
• Study First Submitted QC: 2016-07-29
• Study First Posted: 2016-08-03
• Last Update Submitted: 2016-08-31
• Primary Completion: 2016-09
• Last Update Posted: 2016-09-01
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• All patients with recurrent mitral regurgitation treated with a MitraClip®.

Exclusion Criteria

• Patient with endocarditis,
• Patients with torn mitral valve ring.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival	1 year
MR (mitral regurgitation) grade after clip treatment	1 year	Scale 0-4

Secondary Outcome Measures

Name	Time	Method
NYHA status at latest follow up	1 year
Distance in 6 minute walk test at latest follow up	1 year
MR (mitral regurgitation) grade at latest follow up	1 year	Scale 0-4
LVEF (left ventricular ejection fraction) at latest follow up	1 year
LVEDV (left ventricular enddiastolic volume) at latest follow up	1 year
LVEDD (lef ventricular enddiastolic diameter) at latest follow up	1 year
Mean mitral valve gradient	1 year
Death, recurrent mitral regurgitation grade > 2, repeat intervention/operation of mitral valve	1 year	combined endpoint defined as freedom from each Event (death, MR grade \>2 or reintervention/Operation)
Procedural complications	index procedure
Clip success based on type of sMVR	index procedure	success defined as reduction of 1 MR grade (scale 0-4)

Trial Locations

Locations (1)

Munich University Hospital; 🇩🇪 Munich, Bavaria, Germany