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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: Ablation using CARTO system

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 04-141
    • Military Institute of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Visitag group; Ablation using CARTO system. Visitag module: automated algorithm to collect RF ablation points using Visitag module. Criteria of ablation point: catheter stability range of motion ≤2.5mm, catheter stability time >15sec, contact force >5g over >50% of time. Optimal contact force suggested: 10-40g.	Procedure: Ablation using CARTO system; 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)
Active Comparator: Control group; Ablation using CARTO system. Manual collection of RF ablation points by operator or by assistant. Optimal contact force suggested: 10-40g.	Procedure: Ablation using CARTO system; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AF recurrence	Number of AF recurrence after single catheter ablation during 12 months of follow-up.	1-year follow-up after index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arrhythmia-free survival	Comparison of arrhythmia-free survival curves during the whole follow-up (even if extending over 1 year)	Time to arrhythmia recurrence, follow-up 3-18 months after index procedure

Collaborators and Investigators

• Sponsor: Military Institute of Medicine, Poland
• Investigators: Principal Investigator: Marek Kiliszek, MD, PhD, Military Institute of Medicine

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: June 5, 2015
• First Submitted That Met QC Criteria: June 16, 2015
• First Posted (Estimate): June 19, 2015

Study Record Updates

• Last Update Posted (Actual): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 26, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: atrial fibrillation; pulmonary vein isolation; RF ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 1 (Other Identifier: Mobile Health and Wellness Program)