A Randomised Controlled Pilot Trial: Edge-to-edge Mitral Valve Repair in the Surgical Treatment for Hypertrophic Cardiomyopathy

Meshalkin Research Institute of Pathology of Circulation1 site in 1 country40 target enrollmentMarch 12, 2020

ConditionsHypertrophic Obstructive Cardiomyopathy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hypertrophic Obstructive Cardiomyopathy
Sponsor: Meshalkin Research Institute of Pathology of Circulation
Enrollment: 40
Locations: 1
Primary Endpoint: Left Ventricular Outflow Tract (LVOT) gradient
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

March 12, 2020

End Date

January 31, 2022

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Left Ventricular Outflow Tract (LVOT) gradient

Time Frame: 12 months in the medium-term follow-up

Gradient at the level of the output section of the left ventricle after surgery (mmHg) This measurement will be performed by transthoracic echocardiography at rest and / or during exercise. The Doppler method will be used.