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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

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT02721121

First Posted

March 22, 2016

Last Updated

January 18, 2019

Sponsor

Yonsei University

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

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

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

hnpak@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD

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

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