Serial Hybrid Atrial Fibrillation Ablation

Study Overview
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Brief Summary
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Treatment of (long-standing) persistent atrial fibrillation (AF) remains cumbersome and the surgical (epicardial) approach seems to be the most effective. Still, however a significant amount of failures exist which is mostly due to incompleteness of the surgical ablation lines. Checking, and if necessary additional ablation, of these lines afterwards endocardially by the cardiologist (the so-called serial hybrid approach) could overcome this problem.

Official Title
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Serial Hybrid Atrial Fibrillation Ablation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: Epicardial (surgical) ablation
* Procedure: Hybrid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients are screened and accepted for pulmonary vein isolation according to the current guidelines long standing persistent or persistent AF as defined in the guidelines left atrial size needs to be more than >46 mm on long axis or >35 cc/m2 CHADSVASC score should be more than 0 as an indicator of a substantial substrate for atrial fibrillation. Exclusion Criteria: Significant coronary artery disease has to be excluded as a trigger for AF by means of cardiac CT, if necessary a coronary angiogram will be performed. Previous PVI ablation (epicardial or endocardial) or cardiac surgery. Significant valvular disease present on echo. Concomitant cardiac surgery needed.

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epicardial (surgical) ablation<br>Epicardial Pulmonary vein isolation | Procedure: Epicardial (surgical) ablation<br>* Pulmonary vein isolation with bipolar clamps and bipolar box lesion Epicardial atrial appendage closure<br>|
| Experimental: Hybrid<br>Epicardial (surgical) ablation & Endocardial assessment | Procedure: Hybrid<br>* Epicardial (surgical) ablation Pulmonary vein isolation with bipolar clamps and bipolar box lesion Epicardial atrial appendage closure Endocardial assessment after 6-8 weeks, checking for isolation and if necessary touch up by RF ablation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation Freedom | left sided atrial flutter and left atrial tachycardia | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| re-isolation | number of pulmonary veins needing re-isolation by the EP | 8-10 weeks | 
| Percentage of cross-over | Percentage of cross-over from the surgical arm alone to surgery and serial hybrid ablation. | 1 year | 
| Complications | Number of complications and thrombo-embolic events in both groups | 1 year | 
| Atrial fibrillation Burden | Burden of AF in both groups if AF is still present. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial, fibrillation, pvi, vats, ablation, hybrid