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
1 other identifier
interventional
220
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable atrial-fibrillation
Started Mar 2016
Longer than P75 for not_applicable atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 22, 2016
CompletedFirst Posted
Study publicly available on registry
March 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedJanuary 22, 2019
January 1, 2019
5 years
March 22, 2016
January 18, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Recurrence of atrial fibrillation after catheter ablation
12 month
Secondary Outcomes (3)
procedure time
1 day
procedure related complication rate
12 month
rate of hospitalization
12 month
Study Arms (2)
circumferential pulmonary vein isolation
ACTIVE COMPARATORcircumferential pulmonary vein isolation
Linear ablation in addiction to pulmonary vein isolation
EXPERIMENTALLinear ablation in addiction to pulmonary vein isolation
Interventions
Eligibility Criteria
You may qualify if:
- Patients with persistent Atrial fibrillation (20\~80 years)
- LA diameter \<55mm
- patients possible to anticoagulation and anti arrhythmic drug
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Severance Cardiovascular Hospital, Yonsei University Health System
Seoul, 120-752, South Korea
Related Publications (1)
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.
PMID: 31753429DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2016
First Posted
March 28, 2016
Study Start
March 1, 2016
Primary Completion
March 1, 2021
Study Completion
March 1, 2021
Last Updated
January 22, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share