Mitral Valve Management During Septal Myectomy (MVMSM)

April 5, 2019 updated by: Meshalkin Research Institute of Pathology of Circulation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Novosibirsk, Russian Federation, 630055
        • Novosibirsk State Research Institute of Circulation Pathology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transmitral pressure gradient
Time Frame: 30-days
Transmitral pressure gradient after the procedures assessed by echocardiography
30-days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 10, 2016

Primary Completion (ACTUAL)

October 28, 2016

Study Completion (ACTUAL)

March 20, 2019

Study Registration Dates

First Submitted

January 20, 2019

First Submitted That Met QC Criteria

April 5, 2019

First Posted (ACTUAL)

April 8, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 8, 2019

Last Update Submitted That Met QC Criteria

April 5, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-01-12-3.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Restricted by local policy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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