NCT00477230

Pivotal Clinical Study of Endoscopic Ablation for Atrial Fibrillation (AF) in Patients That Have Failed Drugs

Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic Atrial Fibrillation (AF)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: CardioFocus · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to compare two types of treatment for atrial fibrillation (AF) that are designed to treat the symptoms of atrial fibrillation. The treatments being compared are: * A single catheter ablation procedure with the investigational EAS, a visually-guided, light-energy catheter * Standard drug therapy (antiarrhythmic drugs) To learn more about the CardioFocus ENABLE investigational clinical study, please contact the study site closest to you. Eligibility Criteria Persons with paroxysmal atrial fibrillation may be eligible for this study. Other study eligibility criteria include: * 18 to 80 years of age * Frequent episodes of AF * Failed at least 1 drug treatment for AF (beta-blockers or standard AADs) * Other criteria

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Endoscopic Ablation System	Single ablation procedure with Endoscopic Ablation System
DRUG	Standard Anti-arrhythmic Drug (AAD) Therapy	Medication as prescribed by physician.

Timeline

• Start date: 2007-03-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2007-05-23
• Last updated: 2012-06-27
• Results posted: 2012-06-27

Locations

18 sites across 1 country: United States