Clinical and Economic Consequences of Left Atrial Bipolar Radiofrequency Ablation of Persistent and Permanent Atrial Fibrillation During Cardiac Surgery

Study Overview
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Brief Summary
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The clinical effects of intra-operative radiofrequency ablation in patients with persistent or permanent atrial fibrillation and an indication for an implantation of a heart valve prosthesis or coronary bypass surgery are the purposes of this study. The study will examine if and to what extent the quality of life and the use of medical care differs between patients with and without ablation. Furthermore, there will be thorough echocardiographic examinations of the heart to detect differences between the different treatment groups. The patients will be followed for one year after treatment.

Official Title
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Clinical and Economic Consequences of Left Atrial Bipolar Radiofrequency Ablation of Persistent and Permanent Atrial Fibrillation During Cardiac Surgery. A Prospective Randomized Multi Center Trial

Conditions
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Atrial Fibrillation, Coronary Artery Disease

Intervention / Treatment
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* Procedure: bipolar radiofrequency ablation of persistent and permanent AF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persistent atrial fibrillation Permanent atrial fibrillation Mitral valve defect Tricuspid valve defect Aortic valve defect Coronary artery disease Exclusion Criteria: Pregnancy Age < 18 or > 75 Years Emergency surgery Left dominant coronary circulation (relative contraindication) Coronary arteries of the posterior wall without pathological findings: No inclusion Stenosis of the posterior wall vessels, supplied with a CABG (coronary artery bypass grafting): Inclusion possible Left ventricular ejection fraction < 30% Size of the left atrium > 7 cm Thrombosis of the left atrial appendage Leads in the coronary sinus Atrial flutter Infective endocarditis Reoperation Participation in other studies Life expectancy of less than 12 months Psychiatric disorders Hyperthyreosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Ablation<br> | |
| Other: bipolar radiofrequency ablation of persistent and permanent AF<br>intra operative bipolar RF ablation of persistent and permanent AF | Procedure: bipolar radiofrequency ablation of persistent and permanent AF<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | 12 months | 
| Cost of care |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation |  | 12 months | 
| Echo parameters |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Persistent Atrial Fibrillation, Permanent Atrial Fibrillation, Mitral Valve Defect, Tricuspid Valve Defect, Aortic Valve Defect