Skip to main content
OpenTrials
Completed

NCT Number: NCT05850026

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertrophic Obstructive Cardiomyopathy Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Regurgitation Mitral Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Procedure

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)

Primary outcomes

  1. Survival time after intervention

    Time frame: through study completion, a minimum of 2 years

  2. freedom from reintervention

    Time frame: through study completion, a minimum of 2 years

Sponsors and collaborators

Lead sponsor

Michele De Bonis

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 9, 2023
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.