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

Keimyung University

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: Ablation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02364401

DSMCEP_PHS_001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

50 participants in 2 patient groups

Impedance Guided Ablation Group

Experimental group

Description:

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.

Treatment:

Device: Ablation

Contact Forced Guided Ablation Group

Active Comparator group

Description:

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.

Treatment:

Device: Ablation