Study of HD Mesh Ablation System for Treatment of Paroxysmal Atrial Fibrillation (MAGELLAN)

C. R. Bard

Status and phase: Terminated; Phase 3

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Device: HD Mesh Ablation System; Drug: Anti-arrhythmic drugs

Study type: Interventional

Funder types: Industry

Identifiers

NCT00741611

IDE # G070179

BEP-4408-2007

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Mesh

Experimental group

Description:

Ablation with HD Mesh Ablation System

Treatment:

Device: HD Mesh Ablation System

Drug

Active Comparator group

Description:

Treatment with anti-arrhythmic drugs

Treatment:

Drug: Anti-arrhythmic drugs