MitraClip in Acute Mitral Regurgitation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2021-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Mitral Regurgitation Acute Myocardial Infarction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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MitraClip

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No