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OpenTrials
Completed

NCT Number: NCT03107455

MitraClip in Acute Mitral Regurgitation

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.

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Key information

Conditions

Mitral Regurgitation Acute Myocardial Infarction Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Composite primary end point

    Time frame: 6 month

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

Sponsors and collaborators

Lead sponsor

Fundación Investigación Sanitaria en León

Other

Collaborators

  • Abbott Medical Devices

Registry information

Official study title

European Registry of MitraClip in Acute Myocardial Infarction

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
Apr 11, 2017
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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