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

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ClinicalTrials.gov Identifier: NCT04470102
Recruitment Status : Recruiting
First Posted : July 14, 2020
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypertrophic Obstructive Cardiomyopathy Procedure: mitral valve repair by edge-to-edge technique Procedure: Septal myectomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized clinical trial comparing mitral valve repair using the edge-to-edge technique for surgical treatment of hypertrophic cardiomyopathy
Masking: None (Open Label)
Masking Description: no data
Primary Purpose: Treatment
Official Title: A Randomised Controlled Pilot Trial: Edge-to-edge Mitral Valve Repair in the Surgical Treatment for Hypertrophic Cardiomyopathy
Actual Study Start Date : March 12, 2020
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2022


Arm Intervention/treatment
isolated septal myectomy
Isolated extended septal myectomy
Procedure: Septal myectomy
isolated extended septal myectomy
Other Name: Septal myectomy (SM)

Active Comparator: Septal myectomy+ "edge-to-edge"
advanced septal myectomy in combination with mitral valve repair using the edge-to-edge technique
Procedure: mitral valve repair by edge-to-edge technique
transaortic access for mitral valve repair edge-to-edge
Other Name: Alfieri stitch




Primary Outcome Measures :
  1. Left Ventricular Outflow Tract (LVOT) gradient [ Time Frame: 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 :
  1. Systolic anterior motion of the mitral valve [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04470102


Contacts
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Contact: Alexander V. Bogachev-Prokophiev, MD, PhD +73833476029 bogachev.prokophiev@gmail.com
Contact: Sergei A. Budagaev +73833476029 ser.bud.med@gmail.com

Locations
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Russian Federation
"E.Meshalkin National medical research center" of the Ministry of Health of the Russian Federation Recruiting
Novosibirsk, Russian Federation
Contact: Alexander V. Bogachev-Prokophiev, MD, PhD    +73833476029    bogachev.prokophiev@gmail.com   
Contact: Sergei Budagaev    89021606921    ser.bud.med@gmail.com   
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
Investigators
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Principal Investigator: Alexander V. Bogachev-Prokophiev, MD, PhD E.Meshalkin National medical research center
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Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT04470102    
Other Study ID Numbers: 188
First Posted: July 14, 2020    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meshalkin Research Institute of Pathology of Circulation:
edge-to-edge repair
mitral valve plastic (MVP)
Septal myectomy
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases