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

NCT ID: NCT02474108

Last Updated: 2017-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-02
• Study Completion Date: 2016-10-20

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.

Conditions

Atrial Fibrillation; Rheumatic Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

without prevention

isolated mitral valve replacement or reconstruction, implantation of cardiac monitor

Group Type: PLACEBO_COMPARATOR

cardiomonitor

Intervention Type: DEVICE

in both groups cardiac rhythm will be controlled by a cardiomonitor

group of prevention

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.

Group Type: ACTIVE_COMPARATOR

surgical prevention of atrial fibrillation

Intervention Type: PROCEDURE

Prophylactic surgical ablation is performed to prevent AF in patients during mitral valve surgery. Ablation is performed by radiofrequency electrode or cryoprobe. Pulmonary veins, posterior wall of the left atrium will be isolated by the scheme box-lesion with additional lines to the mitral valve and appendage of left atrium.

cardiomonitor

Intervention Type: DEVICE

in both groups cardiac rhythm will be controlled by a cardiomonitor

Interventions

surgical prevention of atrial fibrillation

Prophylactic surgical ablation is performed to prevent AF in patients during mitral valve surgery. Ablation is performed by radiofrequency electrode or cryoprobe. Pulmonary veins, posterior wall of the left atrium will be isolated by the scheme box-lesion with additional lines to the mitral valve and appendage of left atrium.

Intervention Type: PROCEDURE

cardiomonitor

in both groups cardiac rhythm will be controlled by a cardiomonitor

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

MeshalkinRI

Novosibirsk, , Russia

Countries

Russia

Other Identifiers

SPAF

Identifier Type: -

Identifier Source: org_study_id