MitraClip® After Surgical Mitral Valve Repair

Mitral Regurgitation Clinical Trial

— MVRepair  

Official title:

MitraClip® for the Treatment of Recurrent Severe Mitral Regurgitation After Surgical Mitral Valve Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02853955
• Other study ID #: GE IDE MucS001-16
• Status: Recruiting
• Phase: N/A
• First received: March 31, 2016
• Last updated: August 31, 2016
• Start date: May 2016
• Est. completion date: November 2016

Study information

• Verified date: July 2016
• Source: Klinikum der Universitaet Muenchen
• Contact: Daniel Braun, MD
• Phone: +49 89 4400
• Email: Daniel.Braun[@]med.uni-muenchen.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Device:
• Percutaneous edge-to-edge repair of the mitral valve
MitraClip in patients with recurrent MI after surgical mitral valve repair.

Locations

Country	Name	City	State
Germany	Munich University Hospital	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum der Universitaet Muenchen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival		1 year	No
Primary	MR (mitral regurgitation) grade after clip treatment	Scale 0-4	1 year	No
Secondary	MR (mitral regurgitation) grade at latest follow up	Scale 0-4	1 year	No
Secondary	NYHA status at latest follow up		1 year	No
Secondary	Distance in 6 minute walk test at latest follow up		1 year	No
Secondary	LVEF (left ventricular ejection fraction) at latest follow up		1 year	No
Secondary	LVEDV (left ventricular enddiastolic volume) at latest follow up		1 year	No
Secondary	LVEDD (lef ventricular enddiastolic diameter) at latest follow up		1 year	No
Secondary	Mean mitral valve gradient		1 year	No
Secondary	Procedural complications		index procedure	No
Secondary	Death, recurrent mitral regurgitation grade > 2, repeat intervention/operation of mitral valve	combined endpoint defined as freedom from each Event (death, MR grade >2 or reintervention/Operation)	1 year	No
Secondary	Clip success based on type of sMVR	success defined as reduction of 1 MR grade (scale 0-4)	index procedure	No