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Completed

NCT Number: NCT02476227

Comparison of Operator-guided and Automatic Algorithm-guided Atrial Fibrillation Ablation

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Military Institute of Medicine

Warsaw, 04-141, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with symptomatic atrial fibrillation qualified to catheter ablation according to current standards

Exclusion criteria

  • lack of informed consent
  • two previous pulmonary vein isolations

Treatment and study plan

Ablation using CARTO system

Procedure

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)

Primary outcomes

  1. AF recurrence

    Time frame: 1-year follow-up after index procedure

    Number of AF recurrence after single catheter ablation during 12 months of follow-up.

Secondary outcomes

  1. Arrhythmia-free survival

    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)

Sponsors and collaborators

Lead sponsor

Military Institute od Medicine National Research Institute

Other

Registry information

Official study title

Comparison of Operator-guided and Automatic Algorithm-guided Atrial Fibrillation Ablation. Randomized Open-labeled Study

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jun 19, 2015
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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