Clinical Benefits of Additional Complex Fractionated Atrial Electrogram Targeted Catheter Ablation for Longstanding Persistent Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
atrial electrogram and liner ablation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, catheter ablation, recurrence
Eligibility Criteria
Inclusion Criteria:
1) patients who undergoing catheter ablation of atrial fibrillation due to symptomatic, drug refractory atrial fibrillation
Exclusion Criteria:
- patients who do not agree with study inclusion
- permanent AF refractory to electrical cardioversion
- AF with valvular disease ≥ grade 2
- Patients with left atrial diameter greater than 60mm
- patients with age less than 19
Sites / Locations
- Severance Cardiovascular Hospital, Yonsei University Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
the operation to add in CFAE to conventional liner ablation
only doing conventional liner ablation
Arm Description
The group of positive control is the operation to add in CFAE to conventional liner ablation in persistent atrial fibrillation patients
The group of negative is the operation to only doing conventional liner ablation with persistent atrial fibrillation
Outcomes
Primary Outcome Measures
number of Clinical recurrence of atrial fibrillation (AF) after catheter ablation
lifelong, checked per every outpatient clinic visit
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02175043
Brief Title
Clinical Benefits of Additional Complex Fractionated Atrial Electrogram Targeted Catheter Ablation for Longstanding Persistent Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 3, 2014 (Actual)
Primary Completion Date
February 28, 2017 (Actual)
Study Completion Date
February 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
1. Purpose of the study
1) To compare clinical outcome, procedure time, complication rate of persistent atrial fibrillation patients between conventional additional linear ablation and additional complex fractionated atrial electrogram targeted catheter ablation.
2. Scientific evidence of the study
In atrial fibrillation patients, the maintenance of normal sinus rhythm showed significant reduction of mortality.
drug therapy with anti-arrhythmic drug showed many complications and side effect, thus non-drug therapy such as catheter ablation is developed.
catheter ablation has been performed for 10years world-wide, and showed superior treatment outcome compared with drug therapy.
However, there are no consensus for proper ablation strategy in longstanding persistent atrial fibrillation.
additional ablation make extent of myocardial injury and paradoxically increase recurrence rate, thus still controversial.
Therefore, we will compare conventional linear ablation with additional complex fractionated atrial electrogram targeted catheter ablation.
3. Methods
Treatment of All patients with atrial fibrillation is performed according to the standard treatment guideline of atrial fibrillation.
there is no additional blood sampling, imaging study, or any other invasive procedure according to the inclusion of the study.
4. study contents
to evaluate superior ablation strategy in longstanding persistent atrial fibrillation
compare conventional linear ablation with additional complex fractionated atrial electrogram targeted catheter ablation. both strategies are conventional ablation strategies being performed world-wide.
compare complex fractionated atrial electrogram before and after linear ablation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, catheter ablation, recurrence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
the operation to add in CFAE to conventional liner ablation
Arm Type
Experimental
Arm Description
The group of positive control is the operation to add in CFAE to conventional liner ablation in persistent atrial fibrillation patients
Arm Title
only doing conventional liner ablation
Arm Type
Active Comparator
Arm Description
The group of negative is the operation to only doing conventional liner ablation with persistent atrial fibrillation
Intervention Type
Procedure
Intervention Name(s)
atrial electrogram and liner ablation
Intervention Description
The group of positive control is the operation to add in CFAE to conventional liner ablation in persistent atrial fibrillation patients
The group of negative is the operation to only doing conventional liner ablation with persistent atrial fibrillation
Primary Outcome Measure Information:
Title
number of Clinical recurrence of atrial fibrillation (AF) after catheter ablation
Description
lifelong, checked per every outpatient clinic visit
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1) patients who undergoing catheter ablation of atrial fibrillation due to symptomatic, drug refractory atrial fibrillation
Exclusion Criteria:
patients who do not agree with study inclusion
permanent AF refractory to electrical cardioversion
AF with valvular disease ≥ grade 2
Patients with left atrial diameter greater than 60mm
patients with age less than 19
Facility Information:
Facility Name
Severance Cardiovascular Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Clinical Benefits of Additional Complex Fractionated Atrial Electrogram Targeted Catheter Ablation for Longstanding Persistent Atrial Fibrillation
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