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Surgical Treatment of Hypertrophic Obstructive Cardiomyopathy With Severe Mitral Insufficiency.

Primary Purpose

Hypertrophic Obstructive Cardiomyopathy

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
myoectomy
Mitral valve surgery
Mitral valve surgery
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 hypertrophic cardiomyopathy, mitral valve

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Able to sign Informed Consent and Release of Medical Information forms
  • Age ≥ 18 years
  • obstructive hypertrophic cardiomyopathy
  • surgically significant mitral insufficiency
  • II-IV (NYHA),
  • average systolic pressure gradient greater than 50 mm Hg. Art. at rest;
  • basal or medium ventricular obstruction

Exclusion Criteria:

  • Related defect of the aortic valve;
  • Organic mitral valve disease (dysplasia, rheumatic fever, infective endocarditis);
  • Surgically significant coronary artery lesions;
  • Patients requiring implantation of a cardioverter-defibrillator

Sites / Locations

  • Novosibirsk State Research Institute of Circulation Pathology

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

extended myectomy + MVreplacement

extended myectomy + MVrepair

Arm Description

Procedure: extended myoectomy, mitral valve surgery Will be included in a group of 41 patients with obstructive hypertrophic cardiomyopathy and severe mitral insufficiency. Intraoperatively for all patients will be executed TEE to calculate the volume of excision. All patients will be performed extended myoectomy with full isscheniem subvalvular apparatus and mitral valve replacement. Evaluation results will be made myoectomy as TEE and direct tensiometer.

Procedure: extended myoectomy, mitral valve surgery Will be included in a group of 41 patients with obstructive hypertrophic cardiomyopathy and severe mitral insufficiency. Intraoperatively for all patients will be executed TEE to calculate the volume of excision. All patients will be performed extended myoectomy which supplemented resection and release of the papillary muscles and the mitral valve repair. Results of mitral valve repair will be more appreciated intraoperatively. In case of unsatisfactory MV repair will reconnect the device artificial circulation and mitral valve replacement. There after, patients will be moved to the first group. Evaluation results will be made myoectomy as TEE and direct tensiometer .

Outcomes

Primary Outcome Measures

The function of the mitral valve (mitral regurgitation return, prosthesis dysfunction)

Secondary Outcome Measures

The pressure gradient in the output section of the left ventricle

Full Information

First Posted
December 27, 2013
Last Updated
July 1, 2015
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT02054221
Brief Title
Surgical Treatment of Hypertrophic Obstructive Cardiomyopathy With Severe Mitral Insufficiency.
Official Title
Compare Results of Mitral Valve Replacement or Repair in the Surgical Treatment of Obstructive Hypertrophic Cardiomyopathy With Severe Mitral Insufficiency.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Compare the results of reconstruction and mitral valve replacement in the surgical treatment of obstructive hypertrophic cardiomyopathy with severe mitral insufficiency.
Detailed Description
Many years myoectomy for Morrow was the gold standard in the treatment of obstructive hypertrophic cardiomyopathy. Currently more retrospective data in the literature about the good results the extended septal myectomy. But the question remains what is best for patients with obstructive hypertrophic cardiomyopathy and severe mitral insufficiency: use extended myoectomy with mitral valve repair a or replacement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Obstructive Cardiomyopathy
Keywords
hypertrophic cardiomyopathy, mitral valve

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
extended myectomy + MVreplacement
Arm Type
Other
Arm Description
Procedure: extended myoectomy, mitral valve surgery Will be included in a group of 41 patients with obstructive hypertrophic cardiomyopathy and severe mitral insufficiency. Intraoperatively for all patients will be executed TEE to calculate the volume of excision. All patients will be performed extended myoectomy with full isscheniem subvalvular apparatus and mitral valve replacement. Evaluation results will be made myoectomy as TEE and direct tensiometer.
Arm Title
extended myectomy + MVrepair
Arm Type
Other
Arm Description
Procedure: extended myoectomy, mitral valve surgery Will be included in a group of 41 patients with obstructive hypertrophic cardiomyopathy and severe mitral insufficiency. Intraoperatively for all patients will be executed TEE to calculate the volume of excision. All patients will be performed extended myoectomy which supplemented resection and release of the papillary muscles and the mitral valve repair. Results of mitral valve repair will be more appreciated intraoperatively. In case of unsatisfactory MV repair will reconnect the device artificial circulation and mitral valve replacement. There after, patients will be moved to the first group. Evaluation results will be made myoectomy as TEE and direct tensiometer .
Intervention Type
Procedure
Intervention Name(s)
myoectomy
Other Intervention Name(s)
Extended myoectomy
Intervention Description
The scheme of Extended septal myectomy: Two parallel incisions were made into the septal bulge and connected to remove the muscle mass. Myectomy was extended to the base of the papillary muscles, when midseptal thickening was present. The papillary muscles were grasped and pushed medially to visualize the abnormal connections between the papillary muscles and the anterior wall of the ventricle. A blade was used to divide the thickened abnormal attachments. A pituitary rongeur may be used to resect a portion of the junction of the papillary and lateral wall. This reduces the diameter of the papillary muscle and allows for posterior displacement of the anterior mitral leaflet. Division of abnormal attachments and thinning of the papillary muscles is critical for the treatment of SAM.
Intervention Type
Procedure
Intervention Name(s)
Mitral valve surgery
Other Intervention Name(s)
mitral valve replacement
Intervention Description
41 patients will be performed mitral valve replacement with complete excision of the subvalvular apparatus.
Intervention Type
Procedure
Intervention Name(s)
Mitral valve surgery
Other Intervention Name(s)
mitral valve repair
Intervention Description
41 patients will be performed mitral valve repair. Results of mitral valve repair will be more appreciated intraoperatively. In case of unsatisfactory MV repair will reconnect the device artificial circulation and mitral valve replacement. There after, patients will be moved to the first group.
Primary Outcome Measure Information:
Title
The function of the mitral valve (mitral regurgitation return, prosthesis dysfunction)
Time Frame
one year
Secondary Outcome Measure Information:
Title
The pressure gradient in the output section of the left ventricle
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able to sign Informed Consent and Release of Medical Information forms Age ≥ 18 years obstructive hypertrophic cardiomyopathy surgically significant mitral insufficiency II-IV (NYHA), average systolic pressure gradient greater than 50 mm Hg. Art. at rest; basal or medium ventricular obstruction Exclusion Criteria: Related defect of the aortic valve; Organic mitral valve disease (dysplasia, rheumatic fever, infective endocarditis); Surgically significant coronary artery lesions; Patients requiring implantation of a cardioverter-defibrillator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksandr V Bogachev-Prokophiev, PhD
Organizational Affiliation
Meshalkin Research Institute of Pathology of Circulation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novosibirsk State Research Institute of Circulation Pathology
City
Novosibirsk
State/Province
Novosibirsk territory
ZIP/Postal Code
630055
Country
Russian Federation

12. IPD Sharing Statement

Citations:
Citation
Surgical Treatment of Hypertrophic Obstructive Cardiomyopathy With severe Mitral regurgitation
Results Reference
background
PubMed Identifier
28575282
Citation
Bogachev-Prokophiev A, Afanasyev A, Zheleznev S, Fomenko M, Sharifulin R, Kretov E, Karaskov A. Mitral valve repair or replacement in hypertrophic obstructive cardiomyopathy: a prospective randomized study. Interact Cardiovasc Thorac Surg. 2017 Sep 1;25(3):356-362. doi: 10.1093/icvts/ivx152.
Results Reference
derived

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Surgical Treatment of Hypertrophic Obstructive Cardiomyopathy With Severe Mitral Insufficiency.

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