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

• Status: Terminated
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CardioFocus
• Treatments: Anti-Arrhythmia Agents

Criteria

Inclusion Criteria:

• 18 to 80 years old

• Paroxysmal atrial fibrillation (AF)

• Frequent episodes of AF

• Failed at least 1 drug treatment

• Others

Exclusion Criteria:

• Others