Clinical trial NCT02364401: Impedance vs. Contact Force Guided Atrial Fibrillation Ablation Using Automated Annotation System
Official title: Comparison of Efficacy Between Impedance Guided and Contact Force Guided Atrial Fibrillation Ablation Using Automated Annotation System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Catheter ablation
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
Collaborators: name: Biosense Webster, Inc.
First posted: 2015-02-18
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acute success rate of pulmonary vein isolation obtained after initial circumferential ablation line around pulmonary veins
timeFrame: 6 hours
Secondary outcomes:
measure: Recurrence of any atrial arrhythmias (atrial fibrillation or atrial tachycardia)
timeFrame: 12 months
measure: Procedure time
timeFrame: 6 hours
measure: Ablation time
timeFrame: 6 hours
measure: Average contact force of each ablation lesion
timeFrame: 6 hours
measure: Impedance drop of each ablation lesion
timeFrame: 6 hours
measure: Force time integral of each ablation lesion
timeFrame: 6 hours
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
Study officials:
affiliation: Keimyung University Dongsan Medical Center
name: Hyoung-Seob Park, MD
role: PRINCIPAL_INVESTIGATOR
References: