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

Primary Purpose

Hypertrophic Obstructive Cardiomyopathy

Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
mitral valve repair by edge-to-edge technique
Septal myectomy
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertrophic Obstructive Cardiomyopathy focused on measuring edge-to-edge repair, mitral valve plastic (MVP), Septal myectomy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

isolated septal myectomy

Septal myectomy+ "edge-to-edge"

Arm Description

Isolated extended septal myectomy

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 8, 2020
Last Updated
July 19, 2020
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT04470102
Brief Title
Edge-to-edge Mitral Valve Repair in the Surgical Treatment for Hypertrophic Cardiomyopathy
Acronym
PRIZMA-pilot
Official Title
A Randomised Controlled Pilot Trial: Edge-to-edge Mitral Valve Repair in the Surgical Treatment for Hypertrophic Cardiomyopathy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 12, 2020 (Actual)
Primary Completion Date
January 31, 2021 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Obstructive Cardiomyopathy
Keywords
edge-to-edge repair, mitral valve plastic (MVP), Septal myectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
isolated septal myectomy
Arm Type
Other
Arm Description
Isolated extended septal myectomy
Arm Title
Septal myectomy+ "edge-to-edge"
Arm Type
Active Comparator
Arm Description
advanced septal myectomy in combination with mitral valve repair using the edge-to-edge technique
Intervention Type
Procedure
Intervention Name(s)
mitral valve repair by edge-to-edge technique
Other Intervention Name(s)
Alfieri stitch
Intervention Description
transaortic access for mitral valve repair edge-to-edge
Intervention Type
Procedure
Intervention Name(s)
Septal myectomy
Other Intervention Name(s)
Septal myectomy (SM)
Intervention Description
isolated extended septal myectomy
Primary Outcome Measure Information:
Title
Left Ventricular Outflow Tract (LVOT) gradient
Description
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.
Time Frame
12 months in the medium-term follow-up
Secondary Outcome Measure Information:
Title
Systolic anterior motion of the mitral valve
Description
Systolic anterior motion of the mitral valve after surgery This measurement will be performed by transthoracic echocardiography at rest and / or during exercise.
Time Frame
12 months in the medium-term follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander V. Bogachev-Prokophiev, MD, PhD
Phone
+73833476029
Email
bogachev.prokophiev@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sergei A. Budagaev
Phone
+73833476029
Email
ser.bud.med@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander V. Bogachev-Prokophiev, MD, PhD
Organizational Affiliation
E.Meshalkin National medical research center
Official's Role
Principal Investigator
Facility Information:
Facility Name
"E.Meshalkin National medical research center" of the Ministry of Health of the Russian Federation
City
Novosibirsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander V. Bogachev-Prokophiev, MD, PhD
Phone
+73833476029
Email
bogachev.prokophiev@gmail.com
First Name & Middle Initial & Last Name & Degree
Sergei Budagaev
Phone
89021606921
Email
ser.bud.med@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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