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

Hypertrophic Obstructive Cardiomyopathy Clinical Trial

— PRIZMA-pilot  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04470102
• Other study ID #: 188
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: July 2020
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: Alexander V. Bogachev-Prokophiev, MD, PhD
• Phone: +73833476029
• Email: bogachev.prokophiev[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Obstructive Cardiomyopathy
• Hypertrophy

Intervention

Procedure:
• mitral valve repair by edge-to-edge technique
transaortic access for mitral valve repair edge-to-edge
• Septal myectomy
isolated extended septal myectomy

Locations

Country	Name	City	State
Russian Federation	"E.Meshalkin National medical research center" of the Ministry of Health of the Russian Federation	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left Ventricular Outflow Tract (LVOT) gradient	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.	12 months in the medium-term follow-up
Secondary	Systolic anterior motion of the mitral valve	Systolic anterior motion of the mitral valve after surgery This measurement will be performed by transthoracic echocardiography at rest and / or during exercise.	12 months in the medium-term follow-up