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

Not Applicable

• Conditions: Hypertrophic Obstructive Cardiomyopathy
• Interventions: Procedure: Septal myectomy; Procedure: mitral valve repair by edge-to-edge technique

• Registration Number: NCT04470102
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

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.

Study Timeline

• Study Start: 2020-03-12
• Status Verified: 2020-07
• Study First Submitted: 2020-07-08
• Study First Submitted QC: 2020-07-12
• Study First Posted: 2020-07-14
• Last Update Submitted: 2020-07-19
• Last Update Posted: 2020-07-21
• Primary Completion: 2021-01-31
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
isolated septal myectomy	Septal myectomy	Isolated extended septal myectomy
Septal myectomy+ "edge-to-edge"	mitral valve repair by edge-to-edge technique	advanced septal myectomy in combination with mitral valve repair using the edge-to-edge technique

Primary Outcome Measures

Name	Time	Method
Left Ventricular Outflow Tract (LVOT) gradient	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.

Secondary Outcome Measures

Name	Time	Method
Systolic anterior motion of the mitral valve	12 months in the medium-term follow-up	Systolic anterior motion of the mitral valve after surgery This measurement will be performed by transthoracic echocardiography at rest and / or during exercise.

Trial Locations

Locations (1)

"E.Meshalkin National medical research center" of the Ministry of Health of the Russian Federation; 🇷🇺 Novosibirsk, Russian Federation