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

Not Applicable

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT02364401
• Lead Sponsor: Keimyung University Dongsan Medical Center

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.

Study Timeline

• Study First Submitted: 2015-01-30
• Study Start: 2015-02
• Study First Submitted QC: 2015-02-10
• Study First Posted: 2015-02-18
• Status Verified: 2016-08
• Primary Completion: 2016-11-15
• Study Completion: 2016-12-15
• Last Update Submitted: 2017-08-16
• Last Update Posted: 2017-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Impedance drop of each ablation lesion	6 hours
Force time integral of each ablation lesion	6 hours
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

Trial Locations

Locations (1)

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of