Surgical Treatment of Hypertrophic Obstructive Cardiomyopathy With Severe Mitral Insufficiency.
Compare Results of Mitral Valve Replacement or Repair in the Surgical Treatment of Obstructive Hypertrophic Cardiomyopathy With Severe Mitral Insufficiency.
2 other identifiers
interventional
82
1 country
1
Brief Summary
Compare the results of reconstruction and mitral valve replacement in the surgical treatment of obstructive hypertrophic cardiomyopathy with severe mitral insufficiency.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 27, 2013
CompletedFirst Posted
Study publicly available on registry
February 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedJuly 2, 2015
July 1, 2015
1.6 years
December 27, 2013
July 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The function of the mitral valve (mitral regurgitation return, prosthesis dysfunction)
one year
Secondary Outcomes (1)
The pressure gradient in the output section of the left ventricle
one year
Study Arms (2)
extended myectomy + MVreplacement
OTHERProcedure: 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.
extended myectomy + MVrepair
OTHERProcedure: 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 .
Interventions
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.
41 patients will be performed mitral valve replacement with complete excision of the subvalvular apparatus.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Novosibirsk State Research Institute of Circulation Pathology
Novosibirsk, Novosibirsk Territory, 630055, Russia
Related Publications (2)
Surgical Treatment of Hypertrophic Obstructive Cardiomyopathy With severe Mitral regurgitation
BACKGROUNDBogachev-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.
PMID: 28575282DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aleksandr V Bogachev-Prokophiev, PhD
Meshalkin Research Institute of Pathology of Circulation
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2013
First Posted
February 4, 2014
Study Start
October 1, 2013
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
July 2, 2015
Record last verified: 2015-07