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

NCT05850026 | Completed

• 1 other identifier: MIHOC
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrophic Obstructive Cardiomyopathy; Mitral Regurgitation

Outcome Measures

Primary Outcomes (2)

• Survival time after intervention

  through study completion, a minimum of 2 years

• freedom from reintervention

  through study completion, a minimum of 2 years

Interventions

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with HOCM and MR, who underwent concomitant septal myectomy and mitral valve repair with edge-to-edge technique

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Michele De Bonis: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Cardiac Surgery of Advanced and Research Therapies

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: May 9, 2023
• Study Start: October 5, 2019
• Primary Completion: October 15, 2019
• Study Completion: October 15, 2019
• Last Updated: May 9, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)