Clinical Trials Directory

Trials / Completed

CompletedNCT05850026

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

Status
Completed
Phase
Study type
Observational
Enrollment
26 (actual)
Sponsor
Michele De Bonis · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURESeptal myectomy and mitral valve repair with edge-to-edge techniqueResection of the obstructing part of the interventricular septum and mitral repair using the edge-to-edge technique (suture of leaflets free margins in the regurgitation spot)

Timeline

Start date
2019-10-05
Primary completion
2019-10-15
Completion
2019-10-15
First posted
2023-05-09
Last updated
2023-05-09

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT05850026. Inclusion in this directory is not an endorsement.

Mitral Regurgitation in Hypertrophic Obstructive Cardiomyopathy: Fix it in a Simple, Effective and Durable Way! (NCT05850026) · Clinical Trials Directory