Epicardial Mini-Maze Versus Catheter Ablation for the Management of Persistent Atrial Fibrillation

Study Overview
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Brief Summary
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This study will assess the efficacy of catheter ablation versus the Wolf Mini-Maze surgical ablation for rhythm control in patients with persistent afib.

Detailed Description
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Higher success rates have been achieved after a single surgical ablation when compared to catheter ablation, however contiguous and transmural lesions are not always guaranteed. Even though, catheter ablation is now being offered for symptomatic persistent AF, recurrence after the index procedure in such a persistent AF substrate is not unusual. Redo-catheter ablation is routinely offered for such patients; however long term success still remains low. Non-pulmonary vein triggers are often targeted in such redo-catheter ablation procedures; though this approach remains controversial. More recently, the Wolf Mini-Maze procedure has been utilized with promising results. This study proposes to randomize a group of persistent AF patients to undergo either catheter ablation or the surgical mini-maze procedure with left atrial appendage (LAA) ligation

Official Title
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Epicardial Mini-Maze Versus Catheter Ablation for the Management of Persistent Atrial Fibrillation

Conditions
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Persistent Atrial Fibrillation

Intervention / Treatment
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* Procedure: Catheter ablation
* Procedure: Mini-maze surgical procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persistent symptomatic AF with failure of at least 1 anti-arrhythmic drug Prior pulmonary vein isolation (PVI) CHA2DS2VASC > 0 Able to tolerate and compliant with oral anticoagulation with either Warfarin, dabigatran, rivoraxaban or apixiban Exclusion Criteria: Inability to follow-up as per protocol Prior valvular surgery or valve replacement Reversible cause for atrial fibrillation Currently on dialysis or renal replacement therapy Need for concomitant cardiac surgery History of MI or stroke ≤2 months prior to ablation Intolerance to oral anticoagulants Thrombus in the Left atrial appendage

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: Catheter Ablation<br>Catheter based radiofrequency ablation with wide antral circumferential PVI and isolation of posterior wall will be performed. Mitral and cavo-tricuspid isthmus ablation will be done only if such isthumus dependent flutters are documented prior to / during the procedure. | Procedure: Catheter ablation<br>* Catheter based radiofrequency ablation with wide antral circumferential PVI and isolation of posterior wall will be performed. Mitral and cavo-tricuspid isthmus ablation will be done only if such isthumus dependent flutters are documented prior to / during the procedure.<br>|
| Active Comparator: Mini-maze surgical procedure<br>Wolf Mini-maze surgical ablation along with left atrial appendage ligation will be performed. | Procedure: Mini-maze surgical procedure<br>* Wolf Mini-maze surgical ablation along with left atrial appendage ligation will be performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who are free from atrial fibrillation (AF) |  | 12 months after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who experienced a procedural complication |  | 2 weeks after the procedure | 
| Number of participants who are at risk of stroke |  | 12 months after the procedure | 
| Number of participants who were hospitalized for cardiovascular events |  | 12 months after the procedure | 
| AF burden as assessed by the CCA-SAF | AF burden will be assessed using the Canadian Cardiovascular Society - Severity of Atrial Fibrillation Score (CCA-SAF), which provides objective symptoms severity scoring. | 12 months after the procedure |