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Trial record 4 of 37 for:    mitraclip

MitraClip in Acute Mitral Regurgitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03107455
Recruitment Status : Enrolling by invitation
First Posted : April 11, 2017
Last Update Posted : April 11, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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
Mitral Regurgitation Acute Myocardial Infarction Device: MitraClip

Study Design

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: European Registry of MitraClip in Acute Myocardial Infarction
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : January 1, 2018
Estimated Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    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

Outcome Measures

Primary Outcome Measures :
  1. Composite primary end point [ Time Frame: 6 month ]
    death from cardiac causes, readmission due to heart failure and mitral regurgitation >2+


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03107455


Sponsors and Collaborators
Fundación Investigación Sanitaria en León
Abbott Vascular
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
More Information

Responsible Party: Armando Perez de Prado, MD PhD, Fundación Investigación Sanitaria en León
ClinicalTrials.gov Identifier: NCT03107455     History of Changes
Other Study ID Numbers: EREMMI
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Armando Perez de Prado, Fundación Investigación Sanitaria en León:
MitraClip
Acute mitral regurgitation
Acute myocardial infarction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Mitral Valve Insufficiency
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Heart Valve Diseases