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

NCT ID: NCT02721121

Last Updated: 2019-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2021-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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circumferential pulmonary vein isolation

circumferential pulmonary vein isolation

Group Type ACTIVE_COMPARATOR

circumferential pulmonary vein isolation

Intervention Type PROCEDURE

Linear ablation in addiction to pulmonary vein isolation

Linear ablation in addiction to pulmonary vein isolation

Group Type EXPERIMENTAL

Linear ablation in addiction to circumferential pulmonary vein isolation

Intervention Type PROCEDURE

Interventions

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circumferential pulmonary vein isolation

Intervention Type PROCEDURE

Linear ablation in addiction to circumferential pulmonary vein isolation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance Cardiovascular Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Hui-Nam Pak, M.D., Ph.D.

Role: primary

82-2-2228-8459

References

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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.

Reference Type DERIVED
PMID: 31753429 (View on PubMed)

Other Identifiers

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4-2016-0029

Identifier Type: -

Identifier Source: org_study_id

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