Atrial Fibrillation Clinical Trial
Official title:
Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic Atrial Fibrillation (AF)
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
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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