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

NCT04399499 | Unknown FDA Device

• 1 other identifier: MITRA-SHOCK-2020
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Mitral Regurgitation Functional

Outcome Measures

Primary Outcomes (2)

• Mortality

  30 days

• Mortality

  6 months

Interventions

MitraClip implantation DEVICE

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).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with CS and concomitant severe MR who underwent PMVR between 01/01/2012 to 01/01/2020 will be included in the study. Five Italian centers with high volume of MitraClip procedures will participate in the study. The number of enrolled patients will be of 30 patients. All patients will be older than 18 years old. Patients enrolled at our center (OSR) will be of 10 patients. The patients can tolerate antiplatelets and anticoagulant therapy. Inclusion criteria are: cardiogenic shock, severe mitral regurgitation, prohibitive surgical risk (STS\>10%), anatomic feasibility of PMVR with MitraClip® system. Exclusion criteria are: multiorgan failure, VA-ECMO, inadequate peripheral access because of vascular disease, not suitable mitral valve anatomy.

You may qualify if:

• older than 18 years old

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCSS San Raffaele

Milan, Italy

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 22, 2020
• Study Start: June 1, 2020
• Primary Completion: June 1, 2020
• Study Completion: July 1, 2020
• Last Updated: June 9, 2020

Record last verified: 2020-06

Locations

IT (1)