Mesh Ablator Versus Cryoballoon Pulmonary Vein Ablation of Symptomatic Paroxysmal Atrial Fibrillation

Study Overview
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Brief Summary
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The purpose of this prospective randomized single-center trial is to compare efficiency and safety of two pulmonary vein ablation systems in patients with symptomatic paroxysmal atrial fibrillation using the Arctic Front® versus the HD Mesh Ablator® catheter.

Detailed Description
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Primary objective: • Efficacy of pulmonary vein isolation defined by achieving an exit block for all pulmonary veins per patient. Secondary objectives: Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI prior and within 2 days after PV ablation. Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI within 6 months after PV ablation. Determination of spontaneous recurrence rate of atrial fibrillation using a subcutaneously implanted loop recorder (Reveal XT®). Characterization of non-neurological major complications (death, atrial-esophageal fistula, pulmonary vein stenosis, pericardial tamponade) Rate of iatrogenic interatrial septal defects after transseptal puncture for PV ablation.

Official Title
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HD Mesh Ablator Versus Cryoballoon Pulmonary Vein Ablation of Symptomatic Paroxysmal Atrial Fibrillation - Efficiency and Safety of PV Ablation Systems

Conditions
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Symptomatic Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Procedure: Arctic Front® catheter vs. HD Mesh Ablator® catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with ECG-documented symptomatic paroxysmal atrial fibrillation and at least one ineffective antiarrhythmic drug treatment Exclusion Criteria: Previous ablation procedure for atrial fibrillation or cardiac surgery within 3 months Left atrial diameter > 50mm or ejection fraction < 35% Instable coronary artery disease or clinically relevant cardiac valve insufficiency Hyperthyroidism, pregnancy or lactation; coumadin or heparin intolerance Concomitant disease with expected lifespan < 2 years Contraindications for MRI or acute cerebral infarction detected by brain MRI immediately (< 24 hours) before catheter ablation.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arctic Front® catheter<br> | Procedure: Arctic Front® catheter vs. HD Mesh Ablator® catheter<br>* Pulmonary vein ablation in patients with symptomatic paroxysmal atrial fibrillation using the Arctic Front® catheter versus the HD Mesh Ablator® catheter<br>|
| Active Comparator: HD Mesh Ablator® catheter<br> | Procedure: Arctic Front® catheter vs. HD Mesh Ablator® catheter<br>* Pulmonary vein ablation in patients with symptomatic paroxysmal atrial fibrillation using the Arctic Front® catheter versus the HD Mesh Ablator® catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of pulmonary vein isolation defined by achieving an exit block for all pulmonary veins per patient |  | During ablation procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI |  | within 2 days after catheter ablation | 
| Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI |  | 6 months after catheter ablation | 
| Determination of spontaneous recurrence rate of atrial fibrillation using a subcutaneously implanted loop recorder (Reveal XT®) |  | 1 year after catheter ablation | 
| Characterization of non-neurologic major complications (death, atrial-esophageal fistula, pulmonary vein stenosis, pericardial tamponade) |  | within 1 month after catheter ablation | 
| Rate of iatrogenic interatrial septal defects after transseptal puncture for left-sided atrial catheter ablation |  | 1 year after catheter ablation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, left-sided atrial catheter ablation, paroxysmal atrial fibrillation, cryoballoon technique, mesh ablator catheter, stroke, silent stroke, major complications