NCT03906734

Mitral Valve Management During Septal Myectomy

Alfieri Stich Versus Secondary Cord Cutting During Septal Myectomy in Patients With Hypertrophic Obstructive Cardiomyopathy: A Pilot Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Meshalkin Research Institute of Pathology of Circulation · Network
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Objective of the study: to evaluate whether alfieri technique improves clinical and hemodynamic results compared to transaortic mitral valve secondary cord cutting in patients scheduled to septal myectomy for severely symptomatic hypertrophic obstructive cardiomyopathy.

Detailed description

There is pilot prospective randomised study comparing immediate and early results of additional subvalvular mitral apparatus intervention versus additional alfieri stich in patients scheduled to septal myectomy for symptomatic obstructive cardiomyopathy. Patients with proven hypertrophic cardiomyopathy and resting left ventricle outflow tract obstruction underwent septal myectomy. If patients were suitable for both surgical techniques, they were randomized to alfieri stich or secondary cord cutting. All surgeons were experienced at least 50 related procedures.

Conditions

• Hypertrophic Cardiomyopathy

Interventions

Type	Name	Description
PROCEDURE	Septal myectomy	Transaortic septal myectomy
PROCEDURE	alfieri stich	Transaortic Mitral valve repair using alfieri technique
PROCEDURE	Subvalvular intervention	Transaortic Mitral valve subvalvular intervention including anterior mitral leaflet secondary cord cutting, papillary muscle release

Timeline

• Start date: 2016-01-10
• Primary completion: 2016-10-28
• Completion: 2019-03-20
• First posted: 2019-04-08
• Last updated: 2019-04-08

Locations

1 site across 1 country: Russia