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Completed

NCT Number: NCT03256812

ICT-based Monitoring for Arrhythmia Detection After AF Ablation

To compare the efficacy and stability of an ICT-based centralized clinical trial monitoring system against the efficacy and stability of an existing outpatient-based electrocardiogram (ECG) and Holter monitoring system for arrhythmia detection after atrial fibrillation ablation, and to test whether such continuous monitoring can better detect arrhythmia that is undetectable by existing methods and how this may affect treatment outcomes

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Key information

Conditions

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

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

This clinical trial is a prospective, randomized, controlled, multicenter study in patients who are capable of using and consent to use a smartphone-based ECG monitoring after ablation for atrial fibrillation. The patients will be randomly assigned to either the Holter monitoring or ICT-based centralized clinical trial monitoring system group in a 1:1 ratio and will undergo monitoring from immediately after the procedure to 12 months after discharge.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 20 years, but < 80 years
  • Patients with non-valvular atrial fibrillation
  • Patients with sustained atrial fibrillation despite ≥ 6 weeks of continuous antiarrhythmia therapy or those who underwent an ablation procedure for tachy-bradycardia syndrome within the previous week
  • Patients who can be followed-up for at least 3 months after ablation
  • Patients who can use and consent to use smartphone-based ECG monitoring
  • Patients who can use a smartphone (Android, version 5.0 or lower; development planned for version 6.0 or higher)
  • Those who can connect to the internet via LAN or WiFi and are in an environment where they can use a gateway and smartphone.

Exclusion criteria

  • Patients who cannot be monitored by a smartphone or Bluetooth device
  • Patients who cannot use a smartphone, Bluetooth device, or the internet due to old age
  • Patients with contraindications to standard therapy, such as continued anticoagulant therapy before and after atrial fibrillation ablation
  • Patients belonging to a population vulnerable to clinical trials

Treatment and study plan

ICT-based ECG monitoring

Device

Continuous monitoring will begin from the time of participation in the trial in the ICT-based centralized monitoring group. 24-hr Holter monitoring will be implemented at the 3-, 6-, and 12-month follow-ups in this group, as in the Holter monitoring group. If heart rate drops below 40 beats/min or increases above 120 beats/min on ECG during ICT-based ECG home monitoring, the participant will be notified first through an alarm function.

Holter Monitoring

Device

24-hr Holter monitoring will be implemented at the 3-, 6-, and 12-month follow-ups

Primary outcomes

  1. The difference in arrhythmia detection rate

    Time frame: 12 months

    The difference in arrhythmia detection rate between Holter monitoring and ICT-based centralized monitoring

Secondary outcomes

  1. The difference in the number of hospital visits

    Time frame: 12 months

    The difference in the number of hospital visits during the study period due to arrhythmia

  2. The difference in the recurrence rate of atrial fibrillation or atrial tachycardia

    Time frame: 12 months

    The difference in the recurrence rate of atrial fibrillation or atrial tachycardia within 1 year from atrial fibrillation ablation

Sponsors and collaborators

Lead sponsor

Keimyung University Dongsan Medical Center

Other

Collaborators

  • Daegu Metropolitan City, Korea
  • ICT Clinical Trial Coordination Center
  • Korea Evaluation Institute of Industrial Technology
  • Ministry of Trade, Industry & Energy, Republic of Korea

Registry information

Official study title

Efficacy and Stability of an Information and Communication Technology (ICT)-Based Centralized Monitoring System for Arrhythmia Detection After Atrial Fibrillation Ablation: a Prospective, Randomized Controlled, Multicenter Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 22, 2017
Registry last updated
Oct 18, 2023

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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