NCT05333380

Study on the Effectiveness of AF Analysis Software in AF Rhythm Monitoring

Study on the Effectiveness of Atrial Fibrillation Analysis Software in Atrial Fibrillation Rhythm Monitoring

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 266 (estimated)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: —

Summary

Atrial fibrillation (AF) is a serious public health problem because of its increasing incidence and prevalence in the aging population. ECG is the most commonly used gold standard for clinical diagnosis of arrhythmias, but conventional ECG examinations are not adequate for long-term ECG follow-up measurements in patients with AF. In this study, the AF patients will wear an watch and ECG patch to continuously monitor ECG and PPG. The software uses an integrated diagnostic mechanism of "AF burden + AF segments" to efficiently analyze ECG and PPG data, which can quickly and accurately identify the occurrence of AF and analyze AF burden in real-time, facilitating physicians' diagnosis and treatment and efficacy assessment.

Detailed description

PPG-AF study is a Cohort randomized observational study.The trial will include patients with AF who meet the study requirements from Beijing Anzhen Hospital within 2 months. Each participant will wear an watch and ECG monitor after admission to hospital until Radiofrequency ablation for AF, and after AF ablation until discharge. And more than 18 hours in each period. 1. Primary endpoint. The ECG and PPG data are automatically analyzed by the AF analysis software. The results are compared with expert-annotated gold standard results to verify the sensitivity and specificity. 2. Secondary endpoints. The AF burden calculated from PPG data is compared with that from ECG monitoring, to verify the feasibility of daily monitoring of AF burden using PPG analysis.

Conditions

• Atrial Fibrillation
• Atrial Fibrillation Paroxysmal

Interventions

Type	Name	Description
DEVICE	ECG/PPG monitoring	The enrolled patients will wear an "ECG patch" and watch at the same time to collect ECG and PPG data respectively. The data collection time is from the day of hospitalization to before the ablation operation, and from 2 hours after the removal of ECG monitoring equipment to before leaving the hospital. The monitoring duration of each patient shall not be less than 18 hours.

Timeline

• Start date: 2022-08-29
• Primary completion: 2023-06-01
• Completion: 2023-07-01
• First posted: 2022-04-19
• Last updated: 2022-10-14

Locations

2 sites across 1 country: China