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

Meshalkin Research Institute of Pathology of Circulation

Status: Completed

Conditions: Rheumatic Heart Disease; Atrial Fibrillation

Treatments: Device: cardiomonitor; Procedure: surgical prevention of atrial fibrillation

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02474108

SPAF

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

without prevention

Placebo Comparator group

Description:

isolated mitral valve replacement or reconstruction, implantation of cardiac monitor

Treatment:

Device: cardiomonitor

group of prevention

Active Comparator group

Description:

mitral valve replacement or reconstruction with surgical prevention of AF (concomitant ablation of the left atrium) and implantation of cardiac monitor. Prophylactic surgical ablation is performed to prevent AF in patients during mitral valve surgery. Ablation is performed by radiofrequency electrode or cryoprobe.

Treatment:

Device: cardiomonitor

Procedure: surgical prevention of atrial fibrillation