MitraClip in Acute Mitral Regurgitation

Fundación Investigación Sanitaria en León50 enrolled

Overview

Acute MR may develop in the setting of an acute myocardial infarction (AMI) as a result of papillary muscle dysfunction or rupture, and these patients are grossly underrepresented in MitraClip registries. Our group has recently published the Spanish experience with MitraClip in acute MI, but only 5 patients could be collected. However, the results of our initial experience are highly encouraging since patients performed well in such life-threatening condition. In order to expand the information of the device in this condition, our aim is to start a multinational registry in Europe.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Mitral Regurgitation Acute Myocardial Infarction

Interventions

MitraClipDEVICE

MitraClip consists in two clip arms and opposing grippers, which can be opened and closed against each other in order to grasp and gain cooptation of MV leaflets at the origin of the regurgitant jet

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient ≥ 18 year-old * Transmural myocardial infarction in the previous 4 weeks (managed under current guideline's recommendations). * Symptomatic severe mitral regurgitation diagnosed by left ventriculography, transthoracic echo or trans-oesophageal echo. Symptoms may vary form heart failure to cardiogenic shock. * Symptoms should be stabilized by medical management: iv diuretics, inotropic support, LV assistance devices * Considered by heart team at high risk for conventional surgery Exclusion Criteria: * Anatomy not suitable for MitraClip implantation * Technical contraindication for access to left atrium * Patient candidate for emergent heart transplant * Uncontrolled infection

Outcomes

Primary Outcomes

Composite primary end point

death from cardiac causes, readmission due to heart failure and mitral regurgitation \>2+

Time frame: 6 month