Atrial Fibrillation Registry 2017

Study Overview
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Brief Summary
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Monocentric, prospective, randomized trial of cardiac surgical arrhythmia using endocardial radiofrequency atrial ablation compared with a cryo ablation system in the setting of cardiac surgery.

Detailed Description
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Regular, rhythmic monitoring (24-hour Holter ECG, 5 and 28 days, 3 and 6 months po) of patients after cardiac surgery on the mitral valve with atrial ablation for paroxysmal, persistent, and permanent atrial fibrillation with regard to the presence or stability of sinus rhythm.

Official Title
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Monocentric, Randomized, Prospective Study to Compare Endocardiac Radio Frequency Ablation and Cryo Ablation of the Left Atrium During an Open Chest Mitral Valve Intervention

Conditions
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Atrial Fibrillation, Mitral Valve Failure

Intervention / Treatment
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* Procedure: ablation of left atrium during mitral valve open chest intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 18 years Present, written informed consent from the patient paroxysmal, persistent, or permanent atrial fibrillation not longer than 10 years according to guidelines (ACC, AHA, ESC) planned cardiac surgery on the mitral valve ECHO parameters : LA size a.p. ≤ 55mm Exclusion Criteria: permanent atrial fibrillation longer than 10 years ECHO parameters : LA size a.p. > 55mm pregnancy life expectancy < 12 months lack of cognitive or mental capacity to participate in the study Patients who are to be included in another clinical (interventional) study at the same time or who are already participating in such a study

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: monocentric, 1:1 randomized (cryo ablation vs. radiofrequency ablation), open-label, parallel, registry
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: cryo ablation<br>cryo ablation of left atrium during mitral valve open chest intervention | Procedure: ablation of left atrium during mitral valve open chest intervention<br>* open chest mitral valve surgery (reconstruction or replacement) with additional ablation of left atrium by cryo or radio frequency method<br>|
| Active Comparator: radio frequency ablation<br>radio frequency ablation of left atrium during mitral valve open chest intervention | Procedure: ablation of left atrium during mitral valve open chest intervention<br>* open chest mitral valve surgery (reconstruction or replacement) with additional ablation of left atrium by cryo or radio frequency method<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with stabil sinus rhythm 6 month after ablation | number of patients with stabil sinus rhythm 6 month after ablation | 6 month after index surgery / ablation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sinus rhythm, atrial fibrillation