MitraClip in Acute Mitral Regurgitation
Completed
- Conditions
- Mitral RegurgitationAcute Myocardial Infarction
- Registration Number
- NCT03107455
- Lead Sponsor
- Fundación Investigación Sanitaria en León
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite primary end point 6 month death from cardiac causes, readmission due to heart failure and mitral regurgitation \>2+
- Secondary Outcome Measures
Name Time Method