Edge-to-edge Mitral Valve Repair in the Surgical Treatment for Hypertrophic Cardiomyopathy (PRIZMA-pilot)

Meshalkin Research Institute of Pathology of Circulation

Status: Unknown

Conditions: Hypertrophic Obstructive Cardiomyopathy

Treatments: Procedure: mitral valve repair by edge-to-edge technique; Procedure: Septal myectomy

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT04470102

188

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

isolated septal myectomy

Other group

Description:

Isolated extended septal myectomy

Treatment:

Procedure: Septal myectomy

Septal myectomy+ "edge-to-edge"

Active Comparator group

Description:

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

Treatment:

Procedure: mitral valve repair by edge-to-edge technique