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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02474108
• Other study ID #: SPAF
• Status: Completed
• Phase: N/A
• First received: April 23, 2015
• Last updated: September 8, 2017
• Start date: March 2, 2015
• Est. completion date: October 20, 2016

Study information

• Verified date: September 2017
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 20, 2016
• Est. primary completion date: May 5, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Diseases
• Rheumatic Diseases
• Rheumatic Heart Disease

Intervention

Procedure:
• 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.

Device:
• cardiomonitor
in both groups cardiac rhythm will be controlled by a cardiomonitor

Locations

Country	Name	City	State
Russian Federation	MeshalkinRI	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite outcome measure of complications		up to 1 year
Secondary	number of participants with freedom from AF according to the long-term ECG monitoring		1 year
Secondary	transport function of the left atrium according to TTE (transthoracic echo)		1 year