MitraClip in Acute Mitral Regurgitation

March 15, 2022 updated by: Felipe Fernandez Vazquez, Fundación Investigación Sanitaria en León

European Registry of MitraClip in Acute Myocardial Infarction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Investigación Sanitaria en León

Collaborators

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

March 30, 2017

First Submitted That Met QC Criteria

April 4, 2017

First Posted (Actual)

April 11, 2017

Study Record Updates

Last Update Posted (Actual)

March 16, 2022

Last Update Submitted That Met QC Criteria

March 15, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EREMMI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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