MitraClip in Acute Mitral Regurgitation

NCT03107455 | Completed FDA Device

• 1 other identifier: EREMMI
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mitral Regurgitation; Acute Myocardial Infarction

Keywords

MitraClip; Acute mitral regurgitation; Acute myocardial infarction

Outcome Measures

Primary Outcomes (1)

• Composite primary end point

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

  6 month

Interventions

MitraClip DEVICE

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients experiencing transmural myocardial infarction in the previous 4 weeks and developing secondary mitral regurgitation not responding to medical therapy.

You may qualify if:

• 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

You may not qualify if:

• Anatomy not suitable for MitraClip implantation
• Technical contraindication for access to left atrium
• Patient candidate for emergent heart transplant
• Uncontrolled infection

Sponsors & Collaborators

• Fundación Investigación Sanitaria en León: lead
• Abbott Medical Devices: collaborator

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Rodrigo Estevez-Loureiro, PhD

  University Hospital Leon

  PRINCIPAL INVESTIGATOR

• Carmelo Grasso, PhD

  Ferraroto Hospital Catania

  PRINCIPAL INVESTIGATOR

• Jan Van der Heijden, PhD

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 11, 2017
• Study Start: January 1, 2017
• Primary Completion: July 1, 2019
• Study Completion: December 1, 2021
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share