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

NCT ID: NCT05850026

Last Updated: 2023-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-05

Study Completion Date

2019-10-15

Brief Summary

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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

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Conditions

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Hypertrophic Obstructive Cardiomyopathy Mitral Regurgitation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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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)

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Michele De Bonis

OTHER

Sponsor Role lead

Responsible Party

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Michele De Bonis

Chief of Cardiac Surgery of Advanced and Research Therapies

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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IRCCS Ospedale San Raffaele

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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MIHOC

Identifier Type: -

Identifier Source: org_study_id

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