Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation, Catheter ablation
Brief summary
The purpose of this study is to compare the efficacy of catheter ablation for atrial fibrillation between contact force-guided and impedance-guided annotation using automated annotation system (Visitag™). Patients who receive atrial fibrillation ablation are randomly assigned in the same number to two groups with impedance guided ablation and contact force guided ablation using contact force sensing catheter (THERMOCOOL® SMARTTOUCH™ catheter, Biosense Webster, Inc., Diamond Bar, CA).
Detailed description
During atrial fibrillation ablation, the location where ablation is conducted is displayed through annotation tags using 3D system to recognize energy delivery is done at the area. However this annotation method was unable to identify how effectively the ablation is done. To remedy this disadvantage, automated annotation system (VisiTag™ module, Biosense Webster, Inc., Diamond Bar, CA) was recently developed to make an automatic annotation when all pre-defined criteria are satisfied. But study on the clinical effects of this system is insufficient. The purpose of this study is to compare the efficacy of catheter ablation for atrial fibrillation between contact force-guided and impedance-guided annotation using automated annotation system.
Interventions
DEVICEAblation
Catheter ablation for atrial fibrillation
Sponsors
Biosense Webster, Inc.
Keimyung University Dongsan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with non-valvular atrial fibrillation * Patients having atrial fibrillation even after receiving continued treatment with at least 1 antiarrhythmic drug for more than 6 weeks * Patients with tachycardia-bradycardia syndrome associated with atrial fibrillation. * Patients who can understand the information sheet and consent form on the need and procedure of catheter ablation and submitted them * Patients who are available of follow-up at least for more than three months after catheter ablation
Exclusion criteria
* Patients unsuitable for catheter ablation because the size of left atrium is over 5.5cm * Patients unsuitable for catheter ablation due to previous history of pulmonary surgery or structural heat disease. * Patients who cannot receive standard treatments such as anticoagulation therapy which need to be continuously performed prior to radiofrequency catheter ablation * Patients in the subject group vulnerable to clinical study * Patients who had undergone a prior catheter ablation for atrial fibrillation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute success rate of pulmonary vein isolation obtained after initial circumferential ablation line around pulmonary veins | 6 hours | Acute success is defined as confirmation of entrance block in all pulmonary veins |
Secondary
| Measure | Time frame |
|---|---|
| Procedure time | 6 hours |
| Ablation time | 6 hours |
| Recurrence of any atrial arrhythmias (atrial fibrillation or atrial tachycardia) | 12 months |
| Impedance drop of each ablation lesion | 6 hours |
| Force time integral of each ablation lesion | 6 hours |
| Average contact force of each ablation lesion | 6 hours |
Countries
South Korea
Outcome results
None listed