Mitral Regurgitation in Hypertrophic Obstructive Cardiomyopathy: Fix it in a Simple, Effective and Durable Way!

Completed

• Conditions: Mitral Regurgitation; Hypertrophic Obstructive Cardiomyopathy

• Registration Number: NCT05850026
• Lead Sponsor: Michele De Bonis

Brief Summary

Septal myectomy is performed in selected cases to treat patients with hypertrophic obstructive cardiomyopathy (HOCM). The mechanism that causes obstruction involves both the outflow tract itself and the mitral apparatus, with the appearance of mitral regurgitation (MR) by SAM (Systolic Anterior Motion).

When the interventricular septum is not particularly thick, isolated myectomy may not be sufficient to eliminate the SAM; in these cases the concomitant treatment of the mitral valve is considered. Different approaches have been proposed: mitral replacement with prosthesis, plication or lengthening of the anterior leaflet or the edge-to-edge (EE) technique.

In addition, a small proportion of patients with HOCM may have MR from organic valve abnormalities, requiring specific treatment.

Currently, there are few studies in the literature aimed at determining the role of EE in the context of HOCM; most of these studies are characterized by short follow-up or by the scarcity of echocardiographic data.

The aim of the present study is to evaluate the long-term outcomes of EE associated with septal myectomy in patients with CMIO, both from a clinical point of view and by reporting echocardiographic data.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-05
• Primary Completion: 2019-10-15
• Study Completion: 2019-10-15
• Study First Submitted: 2023-01-27
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-28
• Last Update Submitted: 2023-04-28
• Study First Posted: 2023-05-09
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• diagnosis of HOCM with indication for surgery,
• patients operated on from 2000 to 2017
• contextual diagnosis of MR needing reparative surgical treatment
• age ≥ 18 years

Exclusion Criteria

• hypertophic left ventricle due to other causes (aortic stenosis, arterial hypertension)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival time after intervention	through study completion, a minimum of 2 years
freedom from reintervention	through study completion, a minimum of 2 years

Trial Locations

Locations (1)

IRCCS Ospedale San Raffaele; 🇮🇹 Milan, Italy