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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02364401
• Other study ID #: DSMCEP_PHS_001
• Status: Completed
• Phase: N/A
• First received: January 30, 2015
• Last updated: August 16, 2017
• Start date: February 2015
• Est. completion date: December 15, 2016

Study information

• Verified date: August 2016
• Source: Keimyung University Dongsan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 15, 2016
• Est. primary completion date: November 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Ablation
Catheter ablation for atrial fibrillation

Locations

Country	Name	City	State
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu

Sponsors (2)

Lead Sponsor	Collaborator
Keimyung University Dongsan Medical Center	Biosense Webster, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Recurrence of any atrial arrhythmias (atrial fibrillation or atrial tachycardia)		12 months
Secondary	Procedure time		6 hours
Secondary	Ablation time		6 hours
Secondary	Average contact force of each ablation lesion		6 hours
Secondary	Impedance drop of each ablation lesion		6 hours
Secondary	Force time integral of each ablation lesion		6 hours