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MitraClip in Acute Mitral Regurgitation

Sponsor
Fundación Investigación Sanitaria en León (Other)
Overall Status
Completed
CT.gov ID
NCT03107455
Collaborator
Abbott Medical Devices (Industry)
50
Enrollment
59
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: MitraClip

Study Design

Study Type:
Observational
Actual Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
European Registry of MitraClip in Acute Myocardial Infarction
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Jul 1, 2019
Actual Study Completion Date :
Dec 1, 2021

Outcome Measures

Primary Outcome Measures

  1. Composite primary end point [6 month]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Fundación Investigación Sanitaria en León
  • Abbott Medical Devices

Investigators

  • Principal Investigator: Rodrigo Estevez-Loureiro, PhD, University Hospital Leon
  • Principal Investigator: Carmelo Grasso, PhD, Ferraroto Hospital Catania
  • Principal Investigator: Jan Van der Heijden, PhD, St. Antonius ziekenhuis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Felipe Fernandez Vazquez, MD PhD, Fundación Investigación Sanitaria en León
ClinicalTrials.gov Identifier:
NCT03107455
Other Study ID Numbers:
  • EREMMI
First Posted:
Apr 11, 2017
Last Update Posted:
Mar 16, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Felipe Fernandez Vazquez, MD PhD, Fundación Investigación Sanitaria en León
MitraClip
Acute mitral regurgitation
Acute myocardial infarction
Additional relevant MeSH terms:
Myocardial Infarction
Mitral Valve Insufficiency
Infarction

Study Results

No Results Posted as of Mar 16, 2022