ICT-based Monitoring for Arrhythmia Detection After AF Ablation

NCT03256812 | Completed

• 1 other identifier: ICT_CM_P03_AF
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Arrhythmias, Cardiac; Atrial Fibrillation

Keywords

Arrhythmias, Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• The difference in arrhythmia detection rate

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

  12 months

Secondary Outcomes (2)

• The difference in the number of hospital visits

  12 months

• The difference in the recurrence rate of atrial fibrillation or atrial tachycardia

  12 months

Study Arms (2)

ICT-based ECG monitoring group

EXPERIMENTAL

Continuous monitoring with ICT-based ECG monitoring will begin from the time of participation in the trial in the ICT-based monitoring group. Depending on the lifestyle pattern of the patient, the specific time will be set to allow 30 min of monitoring per day, even if there are no symptoms. If symptoms do appear, additional monitoring will be performed for at least 10 more minutes. 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.

Device: ICT-based ECG monitoring

Holter monitoring group

ACTIVE COMPARATOR

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

Device: Holter monitoring

Interventions

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.

ICT-based ECG monitoring group

Holter monitoring DEVICE

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

Holter monitoring group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Keimyung University Dongsan Medical Center: lead
• Ministry of Trade, Industry & Energy, Republic of Korea: collaborator
• Korea Evaluation Institute of Industrial Technology: collaborator
• Daegu Metropolitan City, Korea: collaborator
• ICT Clinical Trial Coordination Center: collaborator

Study Sites (1)

Keimyung University Dongsan Medical Center

Daegu, 700-712, South Korea

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Hyoung-Seob Park, MD

  Keimyung University Dongsan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 22, 2017
• Study Start: March 1, 2017
• Primary Completion: August 31, 2018
• Study Completion: December 31, 2018
• Last Updated: October 18, 2023

Record last verified: 2019-03

Locations

KR (1)