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Completed

NCT Number: NCT02474108

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

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Bacterial Infections Bacterial Infections and Mycoses Cardiovascular Diseases Gram-Positive Bacterial Infections Heart Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Fever Rheumatic Heart Disease Streptococcal Infections

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MeshalkinRI

Novosibirsk, 630055, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

surgical prevention of atrial fibrillation

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

Device

in both groups cardiac rhythm will be controlled by a cardiomonitor

Primary outcomes

  1. composite outcome measure of complications

    Time frame: up to 1 year

Secondary outcomes

  1. number of participants with freedom from AF according to the long-term ECG monitoring

    Time frame: 1 year

  2. transport function of the left atrium according to TTE (transthoracic echo)

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 17, 2015
Registry last updated
Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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