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OpenTrials
Completed

NCT Number: NCT02364401

Impedance vs. Contact Force Guided Atrial Fibrillation Ablation Using Automated Annotation System

The purpose of this study is to compare the efficacy of catheter ablation for atrial fibrillation between contact force-guided and impedance-guided annotation using automated annotation system (Visitag™). Patients who receive atrial fibrillation ablation are randomly assigned in the same number to two groups with impedance guided ablation and contact force guided ablation using contact force sensing catheter (THERMOCOOL® SMARTTOUCH™ catheter, Biosense Webster, Inc., Diamond Bar, CA).

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Keimyung University Dongsan Medical Center

Daegu, 700-712, South Korea

About this study

During atrial fibrillation ablation, the location where ablation is conducted is displayed through annotation tags using 3D system to recognize energy delivery is done at the area. However this annotation method was unable to identify how effectively the ablation is done. To remedy this disadvantage, automated annotation system (VisiTag™ module, Biosense Webster, Inc., Diamond Bar, CA) was recently developed to make an automatic annotation when all pre-defined criteria are satisfied. But study on the clinical effects of this system is insufficient.

The purpose of this study is to compare the efficacy of catheter ablation for atrial fibrillation between contact force-guided and impedance-guided annotation using automated annotation system.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with non-valvular atrial fibrillation
  • Patients having atrial fibrillation even after receiving continued treatment with at least 1 antiarrhythmic drug for more than 6 weeks
  • Patients with tachycardia-bradycardia syndrome associated with atrial fibrillation.
  • Patients who can understand the information sheet and consent form on the need and procedure of catheter ablation and submitted them
  • Patients who are available of follow-up at least for more than three months after catheter ablation

Exclusion criteria

  • Patients unsuitable for catheter ablation because the size of left atrium is over 5.5cm
  • Patients unsuitable for catheter ablation due to previous history of pulmonary surgery or structural heat disease.
  • Patients who cannot receive standard treatments such as anticoagulation therapy which need to be continuously performed prior to radiofrequency catheter ablation
  • Patients in the subject group vulnerable to clinical study
  • Patients who had undergone a prior catheter ablation for atrial fibrillation

Treatment and study plan

ablation

Device

Catheter ablation for atrial fibrillation

Other names: THERMOCOOL® SMARTTOUCH™ catheter

Primary outcomes

  1. Acute success rate of pulmonary vein isolation obtained after initial circumferential ablation line around pulmonary veins

    Time frame: 6 hours

    Acute success is defined as confirmation of entrance block in all pulmonary veins

Secondary outcomes

  1. Recurrence of any atrial arrhythmias (atrial fibrillation or atrial tachycardia)

    Time frame: 12 months

  2. Procedure time

    Time frame: 6 hours

  3. Ablation time

    Time frame: 6 hours

  4. Average contact force of each ablation lesion

    Time frame: 6 hours

  5. Impedance drop of each ablation lesion

    Time frame: 6 hours

  6. Force time integral of each ablation lesion

    Time frame: 6 hours

Sponsors and collaborators

Lead sponsor

Keimyung University Dongsan Medical Center

Other

Collaborators

  • Biosense Webster, Inc.

Registry information

Official study title

Comparison of Efficacy Between Impedance Guided and Contact Force Guided Atrial Fibrillation Ablation Using Automated Annotation System

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 18, 2015
Registry last updated
Aug 21, 2017

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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