Back to resultsAF Ablation Based on High Density Voltage Mapping and CFAE
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
pulmonary vein isolation
Low-Voltage & CFAE guided ablation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- Age over 20 years old and under 80 years old
- 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 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 6.0 cm
- 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
Sites / Locations
- Keimyung University Dongsan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Low-Voltage & CFAE guided ablation
PV Isolation Only
Arm Description
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)
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Complication rate
Compare complication rate between two groups
Total procedure time, ablation time and fluoroscopy time
Compare total procedure time, ablation time and fluoroscopy time between two groups
Full Information
NCT ID
NCT03046043
First Posted
February 3, 2017
Last Updated
February 20, 2020
Sponsor
Keimyung University Dongsan Medical Center
Collaborators
Biosense Webster, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03046043
Brief Title
AF Ablation Based on High Density Voltage Mapping and CFAE
Official Title
Ablation of Persistent Atrial Fibrillation Based on High Density Voltage Mapping and Complex Fractionated Atrial Electrogram
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
December 23, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Keimyung University Dongsan Medical Center
Collaborators
Biosense Webster, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low-Voltage & CFAE guided ablation
Arm Type
Experimental
Arm Description
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)
Arm Title
PV Isolation Only
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
pulmonary vein isolation
Intervention Description
pulmonary vein isolation is conducted on the junction between the left atrium and pulmonary vein
Intervention Type
Procedure
Intervention Name(s)
Low-Voltage & CFAE guided ablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Free from atrial arrhythmia at 12 months
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Complication rate
Description
Compare complication rate between two groups
Time Frame
12 months
Title
Total procedure time, ablation time and fluoroscopy time
Description
Compare total procedure time, ablation time and fluoroscopy time between two groups
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age over 20 years old and under 80 years old
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 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 6.0 cm
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyoung-Seob Park, MD
Organizational Affiliation
Keimyung University Dongsan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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AF Ablation Based on High Density Voltage Mapping and CFAE
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