Linear Ablation Versus Focal Ablation of Complex Fractionated Atrial Electrograms in Persistent Atrial Fibrillation

NCT ID: NCT01088126

Last Updated: 2018-03-20

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2017-03-02

Brief Summary

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The end point of catheter ablation at complex fractionated atrial electrograms (CFAE) was not established yet. Furthermore, incomplete CFAE ablation may have a potential to develop atrial tachyarrhythmias (AT). The investigators hypothesized that linear ablation extending the clusters of CFAE would be a better strategy than focal ablation at the individual CFAE sites.

Detailed Description

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Conditions

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Persistent 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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Focal ablation

PV isolation + CFAE-targeted focal ablation

Group Type ACTIVE_COMPARATOR

radiofrequency catheter ablation

Intervention Type PROCEDURE

radiofrequency catheter ablation, NavX system

Linear ablation

PV isolation + CFAE-guided linear ablation

Group Type ACTIVE_COMPARATOR

radiofrequency catheter ablation

Intervention Type PROCEDURE

radiofrequency catheter ablation, NavX system

Interventions

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radiofrequency catheter ablation

radiofrequency catheter ablation, NavX system

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients age 18 or greater
* persistent atrial fibrillation
* candidates for AF ablation based on AF that is symptomatic and refractory to at least one antiarrhythmic medication
* at least one episode of AF must have been documented by ECG or Holter within 12 months of randomization in the trial
* continuous anticoagulation with warfarin (INR 2-3) for \>4 weeks prior to the ablation
* patients must be able and willing to provide written informed consent to participate in the clinical trial

* left atrial thrombus on TEE prior to procedure
* contraindications to systemic anticoagulation with heparin or coumadin
* previously undergone atrial fibrillation ablation
* patients who are or may potentially be pregnant

Exclusion Criteria

* paroxysmal or permanent atrial fibrillation
* patients with AF felt to be secondary to an obvious reversible cause
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea University Anam Hospital

OTHER

Sponsor Role lead

Responsible Party

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Korea University Anam Hospital

Principal Investigators

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Young-Hoon Kim, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Korea University

Locations

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Korea University Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AN09239

Identifier Type: -

Identifier Source: org_study_id

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