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

Recruiting

• Conditions: Atrial Fibrillation Paroxysmal; Atrial Fibrillation

• Registration Number: NCT05333380
• Lead Sponsor: Beijing Anzhen Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2022-04-01
• Study First Submitted QC: 2022-04-10
• Study First Posted: 2022-04-19
• Study Start: 2022-08-29
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-13
• Last Update Posted: 2022-10-14
• Primary Completion: 2023-06
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 266

Inclusion Criteria

• Be at least 18 years of age.
• Have clear ECG-recorded atrial fibrillation in the past and will undergo atrial fibrillation ablation in the current hospitalization.
• Patients who agree to wear both the watch and the ECG recorder.

Exclusion Criteria

• Inability to wear the watch due to limited mobility or other problems.
• Severe skin diseases such as skin allergies or skin ulcers.
• Chronic insomnia not treated with medication.
• Patients with severe cardiovascular disease who may be resuscitated at any time.
• Previous history of Parkinson's, schizophrenia, epilepsy.
• Black people and those with excessively dark skin.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The ECG and PPG data are automatically analyzed by the AF analysis software.	Two months after enrollment of the first subject	The results are compared with expert-annotated gold standard results to verify the sensitivity and specificity.

Secondary Outcome Measures

Name	Time	Method
The AF burden calculated from PPG data is compared with that from ECG monitoring.	Two months after enrollment of the first subject	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.

Trial Locations

Locations (1)

Beijing Anzhen Hospital; 🇨🇳 Beijing, Beijing, China