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ICT-based Monitoring for Arrhythmia Detection After AF Ablation

NCT03256812 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-10-18

No results posted yet for this study

Summary

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

Conditions

Interventions

DEVICE

ICT-based ECG monitoring

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.

DEVICE

Holter monitoring

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

Sponsors & Collaborators

  • Ministry of Trade, Industry & Energy, Republic of Korea

    collaborator OTHER_GOV

  • Korea Evaluation Institute of Industrial Technology

    collaborator OTHER

  • Daegu Metropolitan City, Korea

    collaborator OTHER_GOV

  • ICT Clinical Trial Coordination Center

    collaborator OTHER

  • Keimyung University Dongsan Medical Center

    lead OTHER

Principal Investigators

  • Hyoung-Seob Park, MD · Keimyung University Dongsan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2018-08-31
Completion
2018-12-31

Countries

  • South Korea

Study Locations

More Related Trials

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 NCT03256812 on ClinicalTrials.gov