Mitral Valve Management During Septal Myectomy

NCT ID: NCT03906734

Last Updated: 2019-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-10

Study Completion Date

2019-03-20

Brief Summary

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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

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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.

Conditions

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Hypertrophic Cardiomyopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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alfieri technique + Septal myectomy

Septal myectomy plus mitral valve repair using alfieri stich

Group Type EXPERIMENTAL

Septal myectomy

Intervention Type PROCEDURE

Transaortic septal myectomy

alfieri stich

Intervention Type PROCEDURE

Transaortic Mitral valve repair using alfieri technique

Subvalvular intervention + Septal myectomy

Septal myectomy plus subvalvular mitral valve intervention

Group Type ACTIVE_COMPARATOR

Septal myectomy

Intervention Type PROCEDURE

Transaortic septal myectomy

Subvalvular intervention

Intervention Type PROCEDURE

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

Interventions

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Septal myectomy

Transaortic septal myectomy

Intervention Type PROCEDURE

alfieri stich

Transaortic Mitral valve repair using alfieri technique

Intervention Type PROCEDURE

Subvalvular intervention

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novosibirsk State Research Institute of Circulation Pathology

Novosibirsk, , Russia

Site Status

Countries

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Russia

Other Identifiers

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2017-01-12-3.1

Identifier Type: -

Identifier Source: org_study_id

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