Comparison of Circumferential Pulmonary Vein Isolation Alone Versus Linear Ablation in Addition to Circumferential Pulmonary Vein Isolation for Catheter Ablation in Persistent Atrial Fibrillation: Prospective Randomized Controlled Trial
Primary Purpose
Atrial Fibrillation
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
circumferential pulmonary vein isolation
Linear ablation in addiction to circumferential pulmonary vein isolation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- Patients with persistent Atrial fibrillation (20~80 years)
- LA diameter <55mm
- patients possible to anticoagulation and anti arrhythmic drug
Exclusion Criteria:
- Structural cardiac disease
- Contraindication to brain perfusion CT
- Catheter ablation history for AF,
- Cardiac surgery for AF
- active internal bleeding
- Impossible to anticoagulation or antiarrhythmic drug
- valvular AF (MA> GII, Mechanical valve, Mitral valve replacement)
- Patients with severe medical disease
- Expected survival < 1year
- Severe alcoholics, drug addiction
Sites / Locations
- Severance Cardiovascular Hospital, Yonsei University Health SystemRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
circumferential pulmonary vein isolation
Linear ablation in addiction to pulmonary vein isolation
Arm Description
circumferential pulmonary vein isolation
Linear ablation in addiction to pulmonary vein isolation
Outcomes
Primary Outcome Measures
Recurrence of atrial fibrillation after catheter ablation
Secondary Outcome Measures
procedure time
procedure related complication rate
rate of hospitalization
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02721121
Brief Title
Comparison of Circumferential Pulmonary Vein Isolation Alone Versus Linear Ablation in Addition to Circumferential Pulmonary Vein Isolation for Catheter Ablation in Persistent Atrial Fibrillation: Prospective Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the clinical outcomes depending on catheter ablation strategy for persistent atrial fibrillation. After randomization, investigators will conduct circumferential pulmonary vein isolation alone in a group, and additional posterior box isolation and anterior linear ablation in the other group. Investigators will compare clinical recurrence rate, complication rate, and procedure time, etc.
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
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
circumferential pulmonary vein isolation
Arm Type
Active Comparator
Arm Description
circumferential pulmonary vein isolation
Arm Title
Linear ablation in addiction to pulmonary vein isolation
Arm Type
Experimental
Arm Description
Linear ablation in addiction to pulmonary vein isolation
Intervention Type
Procedure
Intervention Name(s)
circumferential pulmonary vein isolation
Intervention Type
Procedure
Intervention Name(s)
Linear ablation in addiction to circumferential pulmonary vein isolation
Primary Outcome Measure Information:
Title
Recurrence of atrial fibrillation after catheter ablation
Time Frame
12 month
Secondary Outcome Measure Information:
Title
procedure time
Time Frame
1 day
Title
procedure related complication rate
Time Frame
12 month
Title
rate of hospitalization
Time Frame
12 month
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:
Patients with persistent Atrial fibrillation (20~80 years)
LA diameter <55mm
patients possible to anticoagulation and anti arrhythmic drug
Exclusion Criteria:
Structural cardiac disease
Contraindication to brain perfusion CT
Catheter ablation history for AF,
Cardiac surgery for AF
active internal bleeding
Impossible to anticoagulation or antiarrhythmic drug
valvular AF (MA> GII, Mechanical valve, Mitral valve replacement)
Patients with severe medical disease
Expected survival < 1year
Severe alcoholics, drug addiction
Facility Information:
Facility Name
Severance Cardiovascular Hospital, Yonsei University Health System
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, M.D., Ph.D.
Phone
82-2-2228-8459
Email
hnpak@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31753429
Citation
Lee JM, Shim J, Park J, Yu HT, Kim TH, Park JK, Uhm JS, Kim JB, Joung B, Lee MH, Kim YH, Pak HN; POBI-AF Investigators. The Electrical Isolation of the Left Atrial Posterior Wall in Catheter Ablation of Persistent Atrial Fibrillation. JACC Clin Electrophysiol. 2019 Nov;5(11):1253-1261. doi: 10.1016/j.jacep.2019.08.021. Epub 2019 Oct 30. Erratum In: JACC Clin Electrophysiol. 2023 Jan;9(1):145.
Results Reference
derived
Learn more about this trial
Comparison of Circumferential Pulmonary Vein Isolation Alone Versus Linear Ablation in Addition to Circumferential Pulmonary Vein Isolation for Catheter Ablation in Persistent Atrial Fibrillation: Prospective Randomized Controlled Trial
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