Mitral Valve Management During Septal Myectomy

Hypertrophic Cardiomyopathy Clinical Trial

— MVMSM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03906734
• Other study ID #: 2017-01-12-3.1
• Status: Completed
• Phase: N/A
• Start date: January 10, 2016
• Est. completion date: March 20, 2019

Study information

• Verified date: April 2019
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 20, 2019
• Est. primary completion date: October 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Hypertrophic obstructive cardiomyopathy

• Left ventricle outflow tract gradient > 50 mm Hg at rest

• Systolic anterior motion mediated mitral regurgitation

Exclusion Criteria:

• Intrinsic valvular heart disease

• Coronary artery disease

• Aortic disease

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy
• Hypertrophy

Intervention

Procedure:
• Septal myectomy
Transaortic septal myectomy
• alfieri stich
Transaortic Mitral valve repair using alfieri technique
• Subvalvular intervention
Transaortic Mitral valve subvalvular intervention including anterior mitral leaflet secondary cord cutting, papillary muscle release

Locations

Country	Name	City	State
Russian Federation	Novosibirsk State Research Institute of Circulation Pathology	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transmitral pressure gradient	Transmitral pressure gradient after the procedures assessed by echocardiography	30-days
Secondary	Repeat bypass	Rate of second cross clamping and repeating bypass for procedure related reasons	30 day
Secondary	Residual left ventricle outflow tract gradient	Residual left ventricle outflow tract gradient assessed by direct measurement	intraoperative measuerment
Secondary	Early mortality	All cause death during 30 days	30 days