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

NCT02476227 | Completed

• 1 other identifier: 1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; pulmonary vein isolation; RF ablation

Outcome Measures

Primary Outcomes (1)

• AF recurrence

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

  1-year follow-up after index procedure

Secondary Outcomes (1)

• Arrhythmia-free survival

  Time to arrhythmia recurrence, follow-up 3-18 months after index procedure

Study Arms (2)

Visitag group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Ablation using CARTO system PROCEDURE

automated algorithm (Visitag)-based vs. manual collection of RF ablation points during AF ablation

Also known as: RF ablation (CARTO system), Pulmonary vein isolation (CARTO system)

Control group; Visitag group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• lack of informed consent
• two previous pulmonary vein isolations

Sponsors & Collaborators

• Military Institute od Medicine National Research Institute: lead

Study Sites (1)

Military Institute of Medicine

Warsaw, 04-141, Poland

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marek Kiliszek, MD, PhD

  Military Institute of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2015
• First Posted: June 19, 2015
• Study Start: April 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: February 1, 2018
• Last Updated: March 29, 2018

Record last verified: 2018-03

Locations

PL (1)