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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2010 by Korea University Anam Hospital. Recruitment status was Recruiting

First Received on March 1, 2010. Last Updated on March 16, 2010 History of Changes

Sponsor:	Korea University Anam Hospital
Information provided by:	Korea University Anam Hospital
ClinicalTrials.gov Identifier:	NCT01088126

Purpose

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.

Condition	Intervention
Persistent Atrial Fibrillation	Procedure: radiofrequency catheter ablation

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

Further study details as provided by Korea University Anam Hospital:

Primary Outcome Measures:

freedom from AF/AT more than 3 months after first ablation [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

freedom from AF/AT within 3 months following first ablation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
acute intra-procedure termination of AF [ Time Frame: 12 months ] [ Designated as safety issue: No ]
organization of AF/conversion to AT during the ablation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
procedure time [ Time Frame: 12 months ] [ Designated as safety issue: No ]
ablation time [ Time Frame: 12 months ] [ Designated as safety issue: No ]
procedure-related complication [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	96
Study Start Date:	January 2010
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01088126

Contacts

Contact: Young-Hoon Kim, M.D., Ph.D	82-2-920-5445	yhkmd@unitel.co.kr
Contact: Jong-Il Choi, M.D., Ph.D	82-2-920-5445	jongilchoi@korea.ac.kr

Locations

Korea, Republic of
Korea University Medical Center	Recruiting
Seoul, Korea, Republic of, 136-705
Contact: Young-Hoon Kim, M.D., Ph.D. 82-2-920-5445 yhkmd@unitel.co.kr
Contact: Jong-Il Choi, M.D., Ph.D 82-2-920-5445 jongilchoi@korea.ac.kr

Sponsors and Collaborators

Korea University Anam Hospital

Investigators

Principal Investigator:

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

Korea University

More Information

No publications provided

Responsible Party:	Young-Hoon Kim, Korea University Anam Hospital
ClinicalTrials.gov Identifier:	NCT01088126 History of Changes
Other Study ID Numbers:	AN09239
Study First Received:	March 1, 2010
Last Updated:	March 16, 2010
Health Authority:	South Korea: Institutional Review Board

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2012