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
Sponsor:
Information provided by:
Korea University Anam Hospital
ClinicalTrials.gov Identifier:
NCT01088126
First received: March 1, 2010
Last updated: March 16, 2010
Last verified: January 2010
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014