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Surgical Prevention of Atrial Fibrillation in Patients With Rheumatic Mitral Valve Lesion and Left Atrium Enlargement

Not Applicable
Completed
Conditions
Rheumatic Heart Disease
Atrial Fibrillation
Registration Number
NCT02474108
Lead Sponsor
Meshalkin Research Institute of Pathology of Circulation
Brief Summary

This study evaluates the safety and efficiency of surgical prevention of atrial fibrillation in patients with valvular heart disease and left atrium enlargement

Detailed Description

Preservation or appearance of AF(atrial fibrillation) after mitral valve surgery substantially reduce the number of excellent and good results of the operation in the long-term period, causing circulatory insufficiency, increased pulmonary hypertension, increasing the risk of thromboembolic events and stroke.

Significant predictors of AF after surgery are the initial size of the left atrium more than 6.0 cm, stenotic lesions and rheumatic genesis of mitral defect. 80% of patients in this group had AF during the first year after operation.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
Inclusion Criteria
  • rheumatic mitral valve lesion
  • the absence a history of AF
  • sinus rhythm
  • left atrium size more than 6.0 cm
Exclusion Criteria
  • refusal to participate in the study
  • aortic stenosis / regurgitation
  • coronary atherosclerosis

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
composite outcome measure of complicationsup to 1 year
Secondary Outcome Measures
NameTimeMethod
number of participants with freedom from AF according to the long-term ECG monitoring1 year
transport function of the left atrium according to TTE (transthoracic echo)1 year

Trial Locations

Locations (1)

MeshalkinRI

🇷🇺

Novosibirsk, Russian Federation

MeshalkinRI
🇷🇺Novosibirsk, Russian Federation

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