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

NCT04399499 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2020-06-09

No results posted yet for this study

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

Conditions

  • Mitral Regurgitation Functional

Interventions

DEVICE

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).

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2020-06-30
Completion
2020-07-31
FDA Device
Yes

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04399499 on ClinicalTrials.gov