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

Mitral Regurgitation Functional Clinical Trial

— MSS  

Official title:

Use of Percutaneous Mitral Leaflet Approach for Severe Mitral Regurgitation in Cardiogenic Shock: Results From a Multicenter Observational Italian Experience (the Mitra-Shock Study).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04399499
• Other study ID #: MITRA-SHOCK-2020
• Status: Recruiting
• Start date: June 2020
• Est. completion date: July 2020

Study information

• Verified date: June 2020
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Mitral Regurgitation Functional
• Mitral Valve Insufficiency
• Shock, Cardiogenic

Intervention

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).

Locations

Country	Name	City	State
Italy	IRCSS San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		30 days
Primary	Mortality		6 months