Atrial Fibrillation Clinical Trial
Official title:
Comparison of Operator-guided and Automatic Algorithm-guided Atrial Fibrillation Ablation. Randomized Open-labeled Study
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.
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.
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