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Completed

NCT Number: NCT03906734

Mitral Valve Management During Septal Myectomy

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.

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Key information

Conditions

Hypertrophic Cardiomyopathy Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Novosibirsk State Research Institute of Circulation Pathology

Novosibirsk, 630055, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Septal myectomy

Procedure

Transaortic septal myectomy

alfieri stich

Procedure

Transaortic Mitral valve repair using alfieri technique

Subvalvular intervention

Procedure

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

Primary outcomes

  1. Transmitral pressure gradient

    Time frame: 30-days

    Transmitral pressure gradient after the procedures assessed by echocardiography

Secondary outcomes

  1. Repeat bypass

    Time frame: 30 day

    Rate of second cross clamping and repeating bypass for procedure related reasons

  2. Residual left ventricle outflow tract gradient

    Time frame: intraoperative measuerment

    Residual left ventricle outflow tract gradient assessed by direct measurement

  3. Early mortality

    Time frame: 30 days

    All cause death during 30 days

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Registry information

Official study title

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

Acronym: MVMSM

Important dates

Study start
2016
Primary completion
2016
Study completion
2019
First posted
Apr 8, 2019
Registry last updated
Apr 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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