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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05850026
Enrollment
26
Registered
2023-05-09
Start date
2019-10-05
Completion date
2019-10-15
Last updated
2023-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic Obstructive Cardiomyopathy, Mitral Regurgitation

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.

Interventions

PROCEDURESeptal 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

Michele De Bonis
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frame
Survival time after interventionthrough study completion, a minimum of 2 years
freedom from reinterventionthrough study completion, a minimum of 2 years

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026