Percutaneous Mitral Valve Repair in Cardiogenic Shock: Mitra-Shock Study

NCT ID: NCT04399499

Last Updated: 2020-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-30

Study Completion Date

2020-07-31

Brief Summary

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Cardiogenic shock (CS) is a medical emergency and a frequent cause of death. CS can be complicated and/or precipitated by mitral regurgitation (MR). The efficacy of percutaneous treatment of MR in patients with cardiogenic shock is unknown. The aims of the study will be to analyse the efficacy of MitraClip therapy on early (30 days) and midterm mortality (6 months) as well as the predictors of outcomes. Investigators will also report the rate of periprocedural complications such as minor and major bleeding, vessel injury and Acute Kidney Injury (AKI).

It is a multicenter retrospective observational study on CE marked medical device (MitraClip® System). Retrospective time range: from 01/01/2012 to 01/01/2020

Detailed Description

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Conditions

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Mitral Regurgitation Functional

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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MitraClip implantation

The MitraClip® procedure is performed under general anesthesia and orotracheal intubation. The procedure is usually guided by 2 and 3-dimensional transesophageal echocardiography and fluoroscopy. This catheter-based technology is inserted through femoral venous access and advanced in the left atrium through the transseptal puncture. The MitraClip® is provided by 2 arms able to grasp the anterior and posterior mitral leaflets. The goal is to approximate both leaflets creating a double orifice mitral valve mimicking the edge-to-edge surgical repair procedure (Alfieri stitch).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* older than 18 years old

Exclusion Criteria

* multiorgan failure,
* VA-ECMO,
* inadequate peripheral access because of vascular disease,
* not suitable mitral valve anatomy.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Agricola Eustachio

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCSS San Raffaele

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Eustachio Agricola, Professor

Role: primary

3386314591

Other Identifiers

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MITRA-SHOCK-2020

Identifier Type: -

Identifier Source: org_study_id

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