Military Institute of Medicine
Warsaw, 04-141, Poland
NCT Number: NCT02476227
Catheter ablation in the treatment of atrial fibrillation (i.e. pulmonary vein isolation) is now the most effective method of prevention of arrhythmia recurrence. Use of 3D electroanatomical system is now a golden standard.
Background hypothesis is that automatic algorithm collecting ablation points during pulmonary vein isolation (with certain catheter stability time, range of motion, and catheter-tissue contact force) prevents forming the gaps in the ablation line, thus preventing pulmonary vein reconnection and AF recurrence. The aim of the trial will be 1:1 comparison of the two methods of pulmonary vein isolation: with manual vs. automatic collection of ablation points using CARTO system and contact force catheter.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Warsaw, 04-141, Poland
Atrial fibrillation (AF) is the most common sustained supraventricular arrhythmia. It increases the risk of hospitalization and all-cause mortality. AF causes about 5-fold increase in the risk of stroke and 3-fold increase in the risk of heart failure.
Catheter ablation in the treatment of AF (i.e. pulmonary vein isolation) is now the most effective method of prevention of arrhythmia recurrence, especially in paroxysmal AF. Still, efficacy of one procedure in a 1-year follow-up is between 20 and 80%, depending on demographic and clinical factors (concomitant diseases), and on the form of the arrhythmia (paroxysmal-persistent), it also depends on the method of ablation used and the experience of the centre. In a big European registry including over 1,300 patients antiarrhythmic drugs-free efficacy of catheter ablation in AF in 1-year follow-up was about 40%. Major finding in patients with AF recurrence after catheter ablation is pulmonary vein reconnection, so decreasing the risk of pulmonary vein reconnections seems crucial to diminish the risk of AF recurrence. Several novel technologies have been proposed lately to improve efficacy of AF ablation, their real importance needs validation in a clinical trial.
Current standard is radiofrequency (RF) ablation with manual collection of ablation points (by operator or assistant). Automatic algorithm collect ablation points with additional criteria: catheter stability time, range of motion, and catheter-tissue contact force. The operator can see more precisely where the RF current has been applied and where are the gaps in the line.
Background hypothesis is that automatic algorithm collecting ablation points (with certain catheter stability time, range of motion, and catheter-tissue contact force) prevents forming the gaps in the ablation line, thus preventing pulmonary vein reconnection and AF recurrence. The aim of the trial will be 1:1 comparison of the two methods of pulmonary vein isolation: with manual vs. automatic collection of ablation points using CARTO system and contact force catheter.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
automated algorithm (Visitag)-based vs. manual collection of RF ablation points during AF ablation
Other names: RF ablation (CARTO system), Pulmonary vein isolation (CARTO system)
Time frame: 1-year follow-up after index procedure
Number of AF recurrence after single catheter ablation during 12 months of follow-up.
Time frame: Time to arrhythmia recurrence, follow-up 3-18 months after index procedure
Comparison of arrhythmia-free survival curves during the whole follow-up (even if extending over 1 year)
Military Institute od Medicine National Research Institute
Other
Comparison of Operator-guided and Automatic Algorithm-guided Atrial Fibrillation Ablation. Randomized Open-labeled Study
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