NCT04519190

Screening for Atrial Fibrillation With Prolonged Continuous Single-lead ECG Devices in High-risk Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: —

Summary

Atrial fibrillation(AF) can be asymptomatic and thus left unidentified in many people, but holds potential risk of lethal complications such as stroke and congestive heart failure. With different screening strategy, the screening result will be different. The longer the monitoring period is, the higher chances AF episodes can be identified, but with greater cost and lower compliance. Therefore, in this study, the investigators want to find the most cost-effective method for AF screening in high risk population with prolonged continuous single-lead ECG device.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Prolonged continuous single-lead ECG monitor	We use Smartpatch, a listed ambulatory electrocardiographic system that can continuously record and save patients' cardiac rhythm for up to 45 days.
DIAGNOSTIC_TEST	Intermittent ECG monitor	When using Smartpatch, we can set time markers by pressing the button on the device. We ask our subjects to press that button twice a day and also when they feel any discomfort. Analyzing the ECG 1 minute after those time markers can serve as a surrogate for intermittent ECG monitor.
DIAGNOSTIC_TEST	Routine practice	Perform pulse palpation and also ECG if irregular rhythm is found.

Timeline

• Start date: 2020-08-25
• Primary completion: 2023-08-31
• Completion: 2023-08-31
• First posted: 2020-08-19
• Last updated: 2020-08-19