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

March 19, 2018 updated by: Korea University Anam Hospital

Comparison of Linear Ablation Versus Focal Ablation of Complex Fractionated Atrial Electrograms After Pulmonary Vein Isolation in Patients With Persistent Atrial Fibrillation: A Prospective & Randomized Controlled Study

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Exclusion Criteria:

  • paroxysmal or permanent atrial fibrillation
  • patients with AF felt to be secondary to an obvious reversible cause
  • inadequate anticoagulation as defined in the inclusion criteria
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Focal ablation
PV isolation + CFAE-targeted focal ablation
Procedure: radiofrequency catheter ablation
radiofrequency catheter ablation, NavX system
Active Comparator: Linear ablation
PV isolation + CFAE-guided linear ablation
Procedure: radiofrequency catheter ablation
radiofrequency catheter ablation, NavX system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
freedom from AF/AT more than 3 months after first ablation
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
freedom from AF/AT within 3 months following first ablation
Time Frame: 3 months
3 months
acute intra-procedure termination of AF
Time Frame: 12 months
12 months
organization of AF/conversion to AT during the ablation
Time Frame: 12 months
12 months
procedure time
Time Frame: 12 months
12 months
ablation time
Time Frame: 12 months
12 months
procedure-related complication
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Anam Hospital

Investigators

  • Principal Investigator: Young-Hoon Kim, M.D., Ph.D., Korea University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

March 2, 2017

Study Registration Dates

First Submitted

March 1, 2010

First Submitted That Met QC Criteria

March 16, 2010

First Posted (Estimate)

March 17, 2010

Study Record Updates

Last Update Posted (Actual)

March 20, 2018

Last Update Submitted That Met QC Criteria

March 19, 2018

Last Verified

January 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN09239

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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