AF Ablation Based on High Density Voltage Mapping and CFAE

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: pulmonary vein isolation; Procedure: Low-Voltage & CFAE guided ablation

• Registration Number: NCT03046043
• Lead Sponsor: Keimyung University Dongsan Medical Center

Brief Summary

The purpose of this study is to evaluate the efficacy of additional ablation targeting complex fractionated atrial electrogram area within low voltage zone identified by high resolution mapping in patients with persistent atrial fibrillation.

Detailed Description

Fifty patients with persistent atrial fibrillation will be randomized a 1:1 ratio to each group. A test group includes those who undergoing ablation targeting low voltage areas which contains complex fractionated trial electrogram in addition to pulmonary vein isolation and a control group includes who undergoing pulmonary vein isolation only.

Study Timeline

• Study First Submitted: 2017-02-03
• Study First Submitted QC: 2017-02-07
• Study First Posted: 2017-02-08
• Study Start: 2017-10-01
• Status Verified: 2019-03
• Primary Completion: 2019-11-30
• Study Completion: 2019-12-23
• Last Update Submitted: 2020-02-20
• Last Update Posted: 2020-02-21

Recruitment & Eligibility

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

Inclusion Criteria

1. Age over 20 years old and under 80 years old
2. Patients with non-valvular atrial fibrillation
3. Patients having atrial fibrillation even after receiving continued treatment with at least 1 antiarrhythmic drug for more than 6 weeks
4. Patients who can understand the information sheet and consent form on the need and procedure of catheter ablation and submitted them
5. Patients who are available of follow-up at least for more than three months after catheter ablation

Exclusion Criteria

1. Patients unsuitable for catheter ablation because the size of left atrium is over 6.0 cm
2. Patients unsuitable for catheter ablation due to previous history of pulmonary surgery or structural heat disease.
3. Patients who cannot receive standard treatments such as anticoagulation therapy which need to be continuously performed prior to radiofrequency catheter ablation
4. Patients in the subject group vulnerable to clinical study
5. Patients who had undergone a prior catheter ablation for atrial fibrillation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-Voltage & CFAE guided ablation	pulmonary vein isolation	* Pulmonary isolation will be performed * Complex fractionated atrial electrogram(CFAE) and voltage mapping will be performed if atrial fibrillation the patient is still in atrial fibrillation after pulmonary vein isolation * CFAE and voltage mapping will be performed simultaneously using small electrode Pentaray® Catheter with CARTO®3 MEM version or CARTO®3 CONFIDENSE™ * Automatic characterization of CFAE signals will be performed with an CARTO® CFAE software module. * CFAE areas within low voltage zone in the left atrium should be targeted first. If atrial fibrillation persist after left atrial ablation, target areas in the right atrium should be mapped and ablated. (Low-Voltage \& CFAE guided ablation)
Low-Voltage & CFAE guided ablation	Low-Voltage & CFAE guided ablation	* Pulmonary isolation will be performed * Complex fractionated atrial electrogram(CFAE) and voltage mapping will be performed if atrial fibrillation the patient is still in atrial fibrillation after pulmonary vein isolation * CFAE and voltage mapping will be performed simultaneously using small electrode Pentaray® Catheter with CARTO®3 MEM version or CARTO®3 CONFIDENSE™ * Automatic characterization of CFAE signals will be performed with an CARTO® CFAE software module. * CFAE areas within low voltage zone in the left atrium should be targeted first. If atrial fibrillation persist after left atrial ablation, target areas in the right atrium should be mapped and ablated. (Low-Voltage \& CFAE guided ablation)
PV Isolation Only	pulmonary vein isolation	* Pulmonary vein isolation will be performed. * Electrical cardioversion to sinus rhythm will be performed if the patient is still in atrial fibrillation after pulmonary vein isolation.

Primary Outcome Measures

Name	Time	Method
Free from atrial arrhythmia at 12 months	12 months	Freedom from any atrial arrhythmia lasting longer than 30 seconds during 1 year follow-up after single ablation with or without the use of antiarrhythmic medications with the exclusion of the 3-month blanking period.

Secondary Outcome Measures

Name	Time	Method
Complication rate	12 months	Compare complication rate between two groups
Total procedure time, ablation time and fluoroscopy time	12 months	Compare total procedure time, ablation time and fluoroscopy time between two groups

Trial Locations

Locations (1)

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