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

NCT04470102 | Unknown DMC

• 1 other identifier: 188
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrophic Obstructive Cardiomyopathy

Keywords

edge-to-edge repair; mitral valve plastic (MVP); Septal myectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Systolic anterior motion of the mitral valve

  12 months in the medium-term follow-up

Study Arms (2)

isolated septal myectomy

OTHER

Isolated extended septal myectomy

Procedure: Septal myectomy

Septal myectomy+ "edge-to-edge"

ACTIVE COMPARATOR

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

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

Interventions

mitral valve repair by edge-to-edge technique PROCEDURE

transaortic access for mitral valve repair edge-to-edge

Also known as: Alfieri stitch

Septal myectomy+ "edge-to-edge"

Septal myectomy PROCEDURE

isolated extended septal myectomy

Also known as: Septal myectomy (SM)

isolated septal myectomy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent (either from the patient or a substitute decision-maker)
• Indications for surgical treatment (septal myectomy) of hypertrophic cardiomyopathy

You may not qualify if:

• indications for mitral valve replacement
• Patient failure at any stage of the study

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (1)

"E.Meshalkin National medical research center" of the Ministry of Health of the Russian Federation

Novosibirsk, Russia

RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Alexander V. Bogachev-Prokophiev, MD, PhD

  E.Meshalkin National medical research center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander V. Bogachev-Prokophiev, MD, PhD

CONTACT

+73833476029; bogachev.prokophiev@gmail.com

Sergei A. Budagaev

CONTACT

+73833476029; ser.bud.med@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: no data
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: A randomized clinical trial comparing mitral valve repair using the edge-to-edge technique for surgical treatment of hypertrophic cardiomyopathy

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 14, 2020
• Study Start: March 12, 2020
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2022
• Last Updated: July 21, 2020

Record last verified: 2020-07

Locations

RU (1)