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

NCT05850026 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 26

Last updated 2023-05-09

No results posted yet for this study

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

  • Hypertrophic Obstructive Cardiomyopathy
  • Mitral Regurgitation

Interventions

PROCEDURE

Septal myectomy and mitral valve repair with edge-to-edge technique

Resection 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)

Sponsors & Collaborators

  • Michele De Bonis

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-05
Primary Completion
2019-10-15
Completion
2019-10-15

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05850026 on ClinicalTrials.gov