Impedance vs. Contact Force Guided Atrial Fibrillation Ablation Using Automated Annotation System

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Efficacy Between Impedance Guided and Contact Force Guided Atrial Fibrillation Ablation Using Automated Annotation System

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Ablation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Impedance Guided Ablation Group<br>Impedance guided ablation group performs pulmonary vein(PV) isolation guided by annotation criteria with minimum time of 10 seconds, maximum range of 2 mm, and minimum impedance decrease over 5 Ohms instead of CF parameters. In the impedance guided group, operators are blinded to contact force data during PV isolation. | Device: Ablation<br>* Catheter ablation for atrial fibrillation<br>* Other names: THERMOCOOL® SMARTTOUCH™ catheter;|
| Active Comparator: Contact Forced Guided Ablation Group<br>Contact force(CF) guided ablation group performs pulmonary vein (PV) isolation guided by automated annotation criteria with minimum time of 10 seconds, maximum range of 2mm, CF over time of 50% and minimum CF of 10 g. | Device: Ablation<br>* Catheter ablation for atrial fibrillation<br>* Other names: THERMOCOOL® SMARTTOUCH™ catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute success rate of pulmonary vein isolation obtained after initial circumferential ablation line around pulmonary veins | Acute success is defined as confirmation of entrance block in all pulmonary veins | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of any atrial arrhythmias (atrial fibrillation or atrial tachycardia) |  | 12 months | 
| Procedure time |  | 6 hours | 
| Ablation time |  | 6 hours | 
| Average contact force of each ablation lesion |  | 6 hours | 
| Impedance drop of each ablation lesion |  | 6 hours | 
| Force time integral of each ablation lesion |  | 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Catheter ablation