Evaluation of Proper Radiofrequency Catheter Ablation Strategy for the Patients Who Were Changed to Paroxysmal Atrial Fibrillation From Persistent Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
linear ablation
pulmonary vein isolation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
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 HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
linear ablation
pulmonary vein isolation
Arm Description
The group of positive control is the operation to add in conventional liner ablation to conventional pulmonary vein isolation with in patients based on patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation
The group of negative is the operation to patients with only pulmonary vein isolation based on patients who were changed to paroxysmal atrial fibrillation from 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
NCT02176616
Brief Title
Evaluation of Proper Radiofrequency Catheter Ablation Strategy for the Patients Who Were Changed to Paroxysmal Atrial Fibrillation From Persistent Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Recruiting
Study Start Date
June 2014 (undefined)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
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 patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation between ablation with conventional pulmonary vein isolation and ablation with conventional pulmonary vein isolation with conventional linear 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 patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation .
additional ablation make extent of myocardial injury and paradoxically increase recurrence rate, thus still controversial.
Therefore, we will compare conventional pulmonary vein isolation with additional conventional linear 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
1) to evaluate superior ablation strategy in patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation
compare conventional pulmonary vein isolation with additional liner ablation, both strategies are conventional ablation strategies being performed world-wide.
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
Investigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
linear ablation
Arm Type
Active Comparator
Arm Description
The group of positive control is the operation to add in conventional liner ablation to conventional pulmonary vein isolation with in patients based on patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation
Arm Title
pulmonary vein isolation
Arm Type
Experimental
Arm Description
The group of negative is the operation to patients with only pulmonary vein isolation based on patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation
Intervention Type
Procedure
Intervention Name(s)
linear ablation
Intervention Description
The group of positive control is the operation to add in conventional liner ablation to conventional pulmonary vein isolation with in patients based on patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation
Intervention Type
Procedure
Intervention Name(s)
pulmonary vein isolation
Intervention Description
The group of negative is the operation to patients with only pulmonary vein isolation based on patients who were changed to paroxysmal atrial fibrillation from 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui-Nam Pak, MD
Phone
82-2-2228-8459
Email
hnpak@yuhs.ac
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui-Nam Pak, MD
Phone
82-2-2228-8459
Email
hnpak@yuhs.ac
12. IPD Sharing Statement
Citations:
PubMed Identifier
32755396
Citation
Pak HN, Park J, Park JW, Yang SY, Yu HT, Kim TH, Uhm JS, Choi JI, Joung B, Lee MH, Kim YH, Shim J. Electrical Posterior Box Isolation in Persistent Atrial Fibrillation Changed to Paroxysmal Atrial Fibrillation: A Multicenter, Prospective, Randomized Study. Circ Arrhythm Electrophysiol. 2020 Sep;13(9):e008531. doi: 10.1161/CIRCEP.120.008531. Epub 2020 Jul 28.
Results Reference
derived
PubMed Identifier
28611206
Citation
Yu HT, Shim J, Park J, Kim IS, Kim TH, Uhm JS, Joung B, Lee MH, Kim YH, Pak HN. Pulmonary Vein Isolation Alone Versus Additional Linear Ablation in Patients With Persistent Atrial Fibrillation Converted to Paroxysmal Type With Antiarrhythmic Drug Therapy: A Multicenter, Prospective, Randomized Study. Circ Arrhythm Electrophysiol. 2017 Jun;10(6):e004915. doi: 10.1161/CIRCEP.116.004915.
Results Reference
derived
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Evaluation of Proper Radiofrequency Catheter Ablation Strategy for the Patients Who Were Changed to Paroxysmal Atrial Fibrillation From Persistent Atrial Fibrillation
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