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Mitral Valve Management During Septal Myectomy (MVMSM)

Primary Purpose

Hypertrophic Cardiomyopathy

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Septal myectomy
alfieri stich
Subvalvular intervention
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertrophic Cardiomyopathy focused on measuring septal myectomy, hypertrophic cardiomyopathy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Novosibirsk State Research Institute of Circulation Pathology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

alfieri technique + Septal myectomy

Subvalvular intervention + Septal myectomy

Arm Description

Septal myectomy plus mitral valve repair using alfieri stich

Septal myectomy plus subvalvular mitral valve intervention

Outcomes

Primary Outcome Measures

Transmitral pressure gradient
Transmitral pressure gradient after the procedures assessed by echocardiography

Secondary Outcome Measures

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

Full Information

First Posted
January 20, 2019
Last Updated
April 5, 2019
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT03906734
Brief Title
Mitral Valve Management During Septal Myectomy
Acronym
MVMSM
Official Title
Alfieri Stich Versus Secondary Cord Cutting During Septal Myectomy in Patients With Hypertrophic Obstructive Cardiomyopathy: A Pilot Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 10, 2016 (Actual)
Primary Completion Date
October 28, 2016 (Actual)
Study Completion Date
March 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Cardiomyopathy
Keywords
septal myectomy, hypertrophic cardiomyopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
alfieri technique + Septal myectomy
Arm Type
Experimental
Arm Description
Septal myectomy plus mitral valve repair using alfieri stich
Arm Title
Subvalvular intervention + Septal myectomy
Arm Type
Active Comparator
Arm Description
Septal myectomy plus subvalvular mitral valve intervention
Intervention Type
Procedure
Intervention Name(s)
Septal myectomy
Intervention Description
Transaortic septal myectomy
Intervention Type
Procedure
Intervention Name(s)
alfieri stich
Intervention Description
Transaortic Mitral valve repair using alfieri technique
Intervention Type
Procedure
Intervention Name(s)
Subvalvular intervention
Intervention Description
Transaortic Mitral valve subvalvular intervention including anterior mitral leaflet secondary cord cutting, papillary muscle release
Primary Outcome Measure Information:
Title
Transmitral pressure gradient
Description
Transmitral pressure gradient after the procedures assessed by echocardiography
Time Frame
30-days
Secondary Outcome Measure Information:
Title
Repeat bypass
Description
Rate of second cross clamping and repeating bypass for procedure related reasons
Time Frame
30 day
Title
Residual left ventricle outflow tract gradient
Description
Residual left ventricle outflow tract gradient assessed by direct measurement
Time Frame
intraoperative measuerment
Title
Early mortality
Description
All cause death during 30 days
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Novosibirsk State Research Institute of Circulation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Restricted by local policy

Learn more about this trial

Mitral Valve Management During Septal Myectomy

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