Study Stopped
It was difficult to enrol patients.
Linear Ablation Versus Focal Ablation of Complex Fractionated Atrial Electrograms in Persistent Atrial Fibrillation
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
1 other identifier
interventional
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 1, 2010
CompletedFirst Posted
Study publicly available on registry
March 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 2, 2017
CompletedMarch 20, 2018
January 1, 2010
1.4 years
March 1, 2010
March 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
freedom from AF/AT more than 3 months after first ablation
12 months
Secondary Outcomes (6)
freedom from AF/AT within 3 months following first ablation
3 months
acute intra-procedure termination of AF
12 months
organization of AF/conversion to AT during the ablation
12 months
procedure time
12 months
ablation time
12 months
- +1 more secondary outcomes
Study Arms (2)
Focal ablation
ACTIVE COMPARATORPV isolation + CFAE-targeted focal ablation
Linear ablation
ACTIVE COMPARATORPV isolation + CFAE-guided linear ablation
Interventions
radiofrequency catheter ablation, NavX system
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- paroxysmal or permanent atrial fibrillation
- patients with AF felt to be secondary to an obvious reversible cause
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Korea University Medical Center
Seoul, 136-705, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Young-Hoon Kim, M.D., Ph.D.
Korea University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 1, 2010
First Posted
March 17, 2010
Study Start
January 1, 2010
Primary Completion
June 1, 2011
Study Completion
March 2, 2017
Last Updated
March 20, 2018
Record last verified: 2010-01