Edge-to-edge Mitral Valve Repair in the Surgical Treatment for Hypertrophic Cardiomyopathy

NCT ID: NCT04470102

Last Updated: 2020-07-21

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-12

Study Completion Date

2022-01-31

Brief Summary

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Objective of the study: to evaluate whether edge-to-edge technique improves clinical and hemodynamic results in patients scheduled to septal myectomy for severely symptomatic hypertrophic obstructive cardiomyopathy.

Detailed Description

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A randomised controlled pilot trial to evaluate whether edge-to-edge technique improves clinical and hemodynamic results in patients scheduled to septal myectomy for severely symptomatic hypertrophic 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 septal myectomy + edge-to-edge mitral valve repair or isolated septal myectomy. All surgeons were experienced at least 50 related procedures.

Conditions

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Hypertrophic Obstructive Cardiomyopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized clinical trial comparing mitral valve repair using the edge-to-edge technique for surgical treatment of hypertrophic cardiomyopathy
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

no data

Study Groups

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isolated septal myectomy

Isolated extended septal myectomy

Group Type OTHER

Septal myectomy

Intervention Type PROCEDURE

isolated extended septal myectomy

Septal myectomy+ "edge-to-edge"

advanced septal myectomy in combination with mitral valve repair using the edge-to-edge technique

Group Type ACTIVE_COMPARATOR

mitral valve repair by edge-to-edge technique

Intervention Type PROCEDURE

transaortic access for mitral valve repair edge-to-edge

Interventions

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mitral valve repair by edge-to-edge technique

transaortic access for mitral valve repair edge-to-edge

Intervention Type PROCEDURE

Septal myectomy

isolated extended septal myectomy

Intervention Type PROCEDURE

Other Intervention Names

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Alfieri stitch Septal myectomy (SM)

Eligibility Criteria

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Inclusion Criteria

* Provide written informed consent (either from the patient or a substitute decision-maker)
* Indications for surgical treatment (septal myectomy) of hypertrophic cardiomyopathy

Exclusion Criteria

* indications for mitral valve replacement
* Patient failure at any stage of the study
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

Principal Investigators

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Alexander V. Bogachev-Prokophiev, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

E.Meshalkin National medical research center

Locations

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"E.Meshalkin National medical research center" of the Ministry of Health of the Russian Federation

Novosibirsk, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Alexander V. Bogachev-Prokophiev, MD, PhD

Role: CONTACT

+73833476029

Sergei A. Budagaev

Role: CONTACT

+73833476029

Facility Contacts

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Alexander V. Bogachev-Prokophiev, MD, PhD

Role: primary

+73833476029

Sergei Budagaev

Role: backup

89021606921

Other Identifiers

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188

Identifier Type: -

Identifier Source: org_study_id

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