AF Ablation Based on High Density Voltage Mapping and CFAE

Ablation of Persistent Atrial Fibrillation Based on High Density Voltage Mapping and Complex Fractionated Atrial Electrogram

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: pulmonary vein isolation; Procedure: Low-Voltage & CFAE guided ablation

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 700-712
    • Keimyung University Dongsan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Procedure: pulmonary vein isolation; pulmonary vein isolation is conducted on the junction between the left atrium and pulmonary vein; Procedure: Low-Voltage & CFAE guided ablation; In CFAE guided ablation,. Within low voltage zone, CFAE areas defined by shortest SCI and high ICL are identified.-Areas with the shortest SCI and high ICL within low voltage areas should be targeted first, followed by longer SCI regions (up to 120ms). Radiofrequency energy is delivered at target sites for 30-60 sec until the local electrogram is completely eliminated.
Active Comparator: PV Isolation Only; 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.	Procedure: pulmonary vein isolation; pulmonary vein isolation is conducted on the junction between the left atrium and pulmonary vein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Free from atrial arrhythmia at 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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication rate	Compare complication rate between two groups	12 months
Total procedure time, ablation time and fluoroscopy time	Compare total procedure time, ablation time and fluoroscopy time between two groups	12 months

Collaborators and Investigators

• Sponsor: Keimyung University Dongsan Medical Center
• Collaborators: Biosense Webster, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): December 23, 2019

Study Registration Dates

• First Submitted: February 3, 2017
• First Submitted That Met QC Criteria: February 7, 2017
• First Posted (Estimate): February 8, 2017

Study Record Updates

• Last Update Posted (Actual): February 21, 2020
• Last Update Submitted That Met QC Criteria: February 20, 2020
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: DSMCEP_PHS_002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No