Study of HD Mesh Ablation System for Treatment of Paroxysmal Atrial Fibrillation

Study Overview
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Brief Summary
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This is a randomized controlled study of the Bard High Density Mesh Ablation System for treatment of paroxysmal atrial fibrillation. This study will determine if the HD Mesh Ablation System is as safe as and more effective than anti-arrhythmic drugs.

Official Title
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A Randomized Controlled Trial of Radiofrequency Ablation for the Treatment of Paroxysmal Atrial Fibrillation Using the Bard High Density Mesh Ablation System (MAGELLAN)

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Device: HD Mesh Ablation System
* Drug: Anti-arrhythmic drugs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with symptomatic paroxysmal atrial fibrillation who have failed at least one class I or III anti-arrhythmic drug Other inclusion criteria Exclusion Criteria: Previous surgical or catheter ablation to treat AF Permanent AF Uncontrolled or unstable medical conditions Other exclusion criteria

Ages Eligible for Study
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Minimum Age: 21 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 |
| --- | --- |
| Experimental: Mesh<br>Ablation with HD Mesh Ablation System | Device: HD Mesh Ablation System<br>* Ablation using the HD Mesh Ablation System<br>|
| Active Comparator: Drug<br>Treatment with anti-arrhythmic drugs | Drug: Anti-arrhythmic drugs<br>* 5 anti-arrhythmic drugs administered at the labeled dosage for atrial fibrillation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Major Complications | A Major Complication was defined as any adverse event that met the following criteria: 1) event was a Serious Adverse Event; 2) event was related to study device (mesh/mesh toolkit) or study procedure and 3)event was a) a cardiovascular adverse event occurring within 7 days of the procedure and/or b) a direct ablation effect adverse event occurring within 12 months of the study procedure. | 12 months | 
| Number of Participants With Serious Atrial Fibrillation Events | Due to the early study termination and the small number of randomized patients (seven), this primary endpoint analysis (comparison of the rate of events in the mesh group to the rate in the drug group) could not be performed. Counts of events occurring in the 36 treated patients are reported by study group instead. | 12 months | 
| Number of Participants With Freedom From Symptomatic Atrial Fibrillation | Due to the early termination and the enrollment of only seven randomized patients, the endpoint was not evaluable. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With the Occurrence of Pulmonary Vein Stenosis in Mesh Treated Patients. | Defined as a greater than or equal to 70% diameter reduction in a pulmonary vein compared with the baseline measurement as assessed by an independent core imaging laboratory. | 12 months | 
| Number of Participants With Acute Procedural Success in Mesh Treated Patients. | Acute procedural success was defined as the ability to isolate 3 of 4 pulmonary veins with the mesh ablation system alone without the need for further ablation with a distal tip catheter | During the mesh ablation procedure |