NCT04470102

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Meshalkin Research Institute of Pathology of Circulation · Network
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertrophic Obstructive Cardiomyopathy

Interventions

Type	Name	Description
PROCEDURE	mitral valve repair by edge-to-edge technique	transaortic access for mitral valve repair edge-to-edge
PROCEDURE	Septal myectomy	isolated extended septal myectomy

Timeline

• Start date: 2020-03-12
• Primary completion: 2021-01-31
• Completion: 2022-01-31
• First posted: 2020-07-14
• Last updated: 2020-07-21

Locations

1 site across 1 country: Russia