MitraClip in Acute Mitral Regurgitation

NCT03107455 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2022-03-16

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Abbott Medical Devices

    collaborator INDUSTRY
  • Fundación Investigación Sanitaria en León

    lead OTHER

Principal Investigators

  • Rodrigo Estevez-Loureiro, PhD · University Hospital Leon

  • Carmelo Grasso, PhD · Ferraroto Hospital Catania

  • Jan Van der Heijden, PhD · St. Antonius Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2019-07-01
Completion
2021-12-01
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03107455 on ClinicalTrials.gov