MVMSM: Mitral Valve Management During Septal Myectomy

Sponsor

Meshalkin Research Institute of Pathology of Circulation (Other)

Overall Status

Completed

CT.gov ID

NCT03906734

Collaborator

(none)

Enrollment

Location

Arms

38.3

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hypertrophic Cardiomyopathy	Procedure: Septal myectomy Procedure: alfieri stich Procedure: Subvalvular intervention	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 10, 2016

Actual Primary Completion Date :

Oct 28, 2016

Actual Study Completion Date :

Mar 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: alfieri technique + Septal myectomy Septal myectomy plus mitral valve repair using alfieri stich	Procedure: Septal myectomy Transaortic septal myectomy Procedure: alfieri stich Transaortic Mitral valve repair using alfieri technique
Active Comparator: Subvalvular intervention + Septal myectomy Septal myectomy plus subvalvular mitral valve intervention	Procedure: Septal myectomy Transaortic septal myectomy Procedure: Subvalvular intervention Transaortic Mitral valve subvalvular intervention including anterior mitral leaflet secondary cord cutting, papillary muscle release

Arm

Intervention/Treatment

Experimental: alfieri technique + Septal myectomy

Septal myectomy plus mitral valve repair using alfieri stich

Procedure: Septal myectomy

Transaortic septal myectomy

Procedure: alfieri stich

Transaortic Mitral valve repair using alfieri technique

Active Comparator: Subvalvular intervention + Septal myectomy

Septal myectomy plus subvalvular mitral valve intervention

Procedure: Septal myectomy

Transaortic septal myectomy

Procedure: Subvalvular intervention

Transaortic Mitral valve subvalvular intervention including anterior mitral leaflet secondary cord cutting, papillary muscle release

Outcome Measures

Primary Outcome Measures

Transmitral pressure gradient [30-days]
Transmitral pressure gradient after the procedures assessed by echocardiography

Secondary Outcome Measures

Repeat bypass [30 day]
Rate of second cross clamping and repeating bypass for procedure related reasons
Residual left ventricle outflow tract gradient [intraoperative measuerment]
Residual left ventricle outflow tract gradient assessed by direct measurement
Early mortality [30 days]
All cause death during 30 days

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novosibirsk State Research Institute of Circulation Pathology	Novosibirsk		Russian Federation	630055

Sponsors and Collaborators

Meshalkin Research Institute of Pathology of Circulation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Meshalkin Research Institute of Pathology of Circulation

ClinicalTrials.gov Identifier:

NCT03906734

Other Study ID Numbers:

2017-01-12-3.1

First Posted:

Apr 8, 2019

Last Update Posted:

Apr 8, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Meshalkin Research Institute of Pathology of Circulation

septal myectomy

hypertrophic cardiomyopathy

Additional relevant MeSH terms:

Cardiomyopathies

Cardiomyopathy, Hypertrophic

Hypertrophy

Study Results

No Results Posted as of Apr 8, 2019