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

Pilot, Randomized,Single Blind Trial of Surgical Prevention of Atrial Fibrillation in Patients With Rheumatic Mitral Valve Lesion

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02474108

Enrollment

Registered

2015-06-17

Start date

2015-03-02

Completion date

2016-10-20

Last updated

2017-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Rheumatic Heart Disease

Keywords

atrial fibrillation, radiofrequency ablation, prevention of AF, mitral valve, left atrium enlargement, cryoablation

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.

Interventions

PROCEDUREsurgical 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.

DEVICEcardiomonitor

in both groups cardiac rhythm will be controlled by a cardiomonitor

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame
composite outcome measure of complications	up to 1 year

Secondary

Measure	Time frame
number of participants with freedom from AF according to the long-term ECG monitoring	1 year
transport function of the left atrium according to TTE (transthoracic echo)	1 year

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026