Comparison of 24-hour Holter Monitoring Versus 14-day Continuous ECG Patch Monitoring EZYPRO

Sigknow Biomedical

Status: Unknown

Conditions: Atrial Fibrillation; Arrhythmias, Cardiac

Treatments: Device: EZYPRO®

Study type: Interventional

Funder types: Industry

Identifiers

NCT03602742

SIGEZYZ20170828

Details and patient eligibility

About

This is an open-label study to investigate the functional features of prolonged monitoring by 14-day EZYPRO® to improve the medical care and/or diagnosis for the patient with arrhythmia. Patients will be enrolled by outpatient basis from two clinical study sites. Enrolled patients will wear a traditional 24-hour Holter monitor and an 14-day EZYPRO® which can provide monitoring data for up to 14 days. This study will allow a direct comparison between two devices.

Enrollment: 150 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of signed written informed consent before enrollment into the study
• Are able to communicate with the investigators
• With suspected arrhythmia related signs and symptoms, judged by the investigators
• Patients intend to wear ECG moniotrs
• Males and females, 20 years of age or older

Exclusion criteria

• Patients with skin allergies or injury, judged by investigators
• Patients with specific arrhythmia or specific treatments, interfere with study evaluations, judged by investigators
• Pregnant women
• Currently participating in another trial or who participated in a previous clinical trial

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

24-hour Holter and 14-day EZYPRO®

Other group

Description:

This is an open-label study to investigate the functional features of prolonged monitoring by 14-day EZYPRO® to improve the medical care and/or diagnosis for the patient with arrhythmia. One arm included.

Treatment:

Device: EZYPRO®