An interventional study of pulmonary vein isolation and Low-Voltage & CFAE guided ablation in Atrial Fibrillation, sponsored by Keimyung University Dongsan Medical Center. Completed at 1 site in South Korea. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-02-21.
Sponsored by Keimyung University Dongsan Medical Center · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy of additional ablation targeting complex fractionated atrial electrogram area within low voltage zone identified by high resolution mapping in patients with persistent atrial fibrillation.
Fifty patients with persistent atrial fibrillation will be randomized a 1:1 ratio to each group. A test group includes those who undergoing ablation targeting low voltage areas which contains complex fractionated trial electrogram in addition to pulmonary vein isolation and a control group includes who undergoing pulmonary vein isolation only.
3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.
This study's enrollment of 50 is below the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Keimyung University Dongsan Medical Center is the lead sponsor of 86 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
* Pulmonary isolation will be performed * Complex fractionated atrial electrogram(CFAE) and voltage mapping will be performed if atrial fibrillation the patient is still in atrial fibrillation after pulmonary vein isolation * CFAE and voltage mapping will be performed simultaneously using small electrode Pentaray® Catheter with CARTO®3 MEM version or CARTO®3 CONFIDENSE™ * Automatic characterization of CFAE signals will be performed with an CARTO® CFAE software module. * CFAE areas within low voltage zone in the left atrium should be targeted first. If atrial fibrillation persist after left atrial ablation, target areas in the right atrium should be mapped and ablated. (Low-Voltage \& CFAE guided ablation)
Procedure: pulmonary vein isolation · Procedure: Low-Voltage & CFAE guided ablation
* Pulmonary vein isolation will be performed. * Electrical cardioversion to sinus rhythm will be performed if the patient is still in atrial fibrillation after pulmonary vein isolation.
Procedure: pulmonary vein isolation
pulmonary vein isolation is conducted on the junction between the left atrium and pulmonary vein
In CFAE guided ablation,. Within low voltage zone, CFAE areas defined by shortest SCI and high ICL are identified.-Areas with the shortest SCI and high ICL within low voltage areas should be targeted first, followed by longer SCI regions (up to 120ms). Radiofrequency energy is delivered at target sites for 30-60 sec until the local electrogram is completely eliminated.
Free from atrial arrhythmia at 12 months
Freedom from any atrial arrhythmia lasting longer than 30 seconds during 1 year follow-up after single ablation with or without the use of antiarrhythmic medications with the exclusion of the 3-month blanking period.
Time frame: 12 months
Complication rate
Compare complication rate between two groups
Time frame: 12 months
Total procedure time, ablation time and fluoroscopy time
Compare total procedure time, ablation time and fluoroscopy time between two groups
Time frame: 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Oct 2017 to primary completion in Nov 2019, 25 months.
Of 789 non-industry interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's 25 months is below that.
Counting every sponsor, half of 1,031 studies reached it within 34 months; a quarter within 18 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Keimyung University Dongsan Medical Center