MitraClip in Acute Mitral Regurgitation

European Registry of MitraClip in Acute Myocardial Infarction

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03107455

Enrollment

Registered

2017-04-11

Start date

2017-01-01

Completion date

2021-12-01

Last updated

2022-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Regurgitation, Acute Myocardial Infarction

Keywords

MitraClip, Acute mitral regurgitation, Acute myocardial infarction

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.

Interventions

DEVICEMitraClip

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Composite primary end point	6 month	death from cardiac causes, readmission due to heart failure and mitral regurgitation \>2+

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026