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

• Sponsor: Michele De Bonis (Other)
• Overall Status: Completed
• CT.gov ID: NCT05850026
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Actual Duration (Days): 10
• Patients Per Site Per Month: 79.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertrophic Obstructive Cardiomyopathy; Mitral Regurgitation	Procedure: Septal myectomy and mitral valve repair with edge-to-edge technique

Study Design

• Study Type: Observational
• Actual Enrollment: 26 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Mitral Regurgitation in Hypertrophic Obstructive Cardiomyopathy: Fix it in a Simple, Effective and Durable Way!
• Actual Study Start Date: Oct 5, 2019
• Actual Primary Completion Date: Oct 15, 2019
• Actual Study Completion Date: Oct 15, 2019

Outcome Measures

Primary Outcome Measures

1. Survival time after intervention [through study completion, a minimum of 2 years]

2. freedom from reintervention [through study completion, a minimum of 2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Ospedale San Raffaele	Milan		Italy	20132

Sponsors and Collaborators

• Michele De Bonis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michele De Bonis, Chief of Cardiac Surgery of Advanced and Research Therapies, Ospedale San Raffaele
• ClinicalTrials.gov Identifier: NCT05850026
• Other Study ID Numbers: MIHOC
• First Posted: May 9, 2023
• Last Update Posted: May 9, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cardiomyopathies; Mitral Valve Insufficiency; Cardiomyopathy, Hypertrophic; Hypertrophy

Study Results

No Results Posted as of May 9, 2023