Atrial Fibrillation, Radiofrequency Ablation
Conditions
Brief summary
Curative catheter ablation has been established as an effective therapeutic option for atrial fibrillation (AF) that is resistant to pharmacologic rhythm or rate control. However, standard ablative approaches targeting the pulmonary veins (PVs) are associated with a success rate as low as 40%. In a recent study, Kumagai et al. described a new approach of catheter ablation of AF isolating the posterior left atrium including all PVs (called Box Isolation). In Kumagai's study, 46 patients with symptomatic AF underwent box isolation. At 6 months follow up, 43 of 46 patients (93%) were arrhythmia free without antiarrhythmic drugs, with a single procedure success rate of 87% (40/46). This study provided new evidence supporting the hypothesis that the posterior wall is of high importance for the maintenance of AF. The aim of the investigators study is to determine the efficacy of two different approaches of catheter ablation (Standard PV Isolation vs. Box isolation) for the treatment of chronic AF.
Interventions
PROCEDUREusual PV ablation
usual PV ablation, per above
PROCEDUREBox isolation of pulmonary veins
as above
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing clinically indicated pulmonary vein ablation for atrial fibrillation.
Exclusion criteria
* Unable to understand consent form. Not scheduled for clinically indicated pulmonary vein ablation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| freedom from atrial fibrillation | 3 months following ablation |
Secondary
| Measure | Time frame |
|---|---|
| safety of Box isolation | 3 months following procedure |
Countries
United States
Outcome results
None listed