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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02474108
Other study ID # SPAF
Secondary ID
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
Health authority
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

Study Design


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
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