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

• Conditions: Mitral Regurgitation Functional

• Registration Number: NCT04399499
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2020-05-18
• Study First Submitted QC: 2020-05-20
• Study First Posted: 2020-05-22
• Status Verified: 2020-06
• Study Start: 2020-06
• Primary Completion: 2020-06
• Last Update Submitted: 2020-06-07
• Last Update Posted: 2020-06-09
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	6 months

Trial Locations

Locations (1)

IRCSS San Raffaele; 🇮🇹 Milan, Italy