MitraClip in Acute Mitral Regurgitation

Acute Myocardial Infarction Clinical Trial

Official title:

European Registry of MitraClip in Acute Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03107455
• Other study ID #: EREMMI
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: December 1, 2021

Study information

• Verified date: March 2022
• Source: Fundación Investigación Sanitaria en León
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 1, 2021
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Mitral Regurgitation
• Mitral Valve Insufficiency
• Myocardial Infarction

Intervention

Device:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Investigación Sanitaria en León	Abbott Medical Devices

Outcome

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