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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04399499
Acronym
MSS
Enrollment
30
Registered
2020-05-22
Start date
2020-06-30
Completion date
2020-07-31
Last updated
2020-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Regurgitation Functional

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

Interventions

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

IRCCS San Raffaele
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Mortality30 days

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026