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

NCT02476227 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2018-03-29

No results posted yet for this study

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

Interventions

PROCEDURE

Ablation using CARTO system

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

Sponsors & Collaborators

  • Military Institute od Medicine National Research Institute

    lead OTHER

Principal Investigators

  • Marek Kiliszek, MD, PhD · Military Institute of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-01-31
Completion
2018-02-28

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02476227 on ClinicalTrials.gov