Study on the Effectiveness of Atrial Fibrillation Analysis Software in Atrial Fibrillation Rhythm Monitoring (PPG-AF)

  • STATUS
    Recruiting
  • End date
    Jul 22, 2023
  • participants needed
    266
  • sponsor
    Beijing Anzhen Hospital
Updated on 22 October 2022
fibrillation
electrocardiographic monitoring

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.

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.

Details
Condition Atrial Fibrillation, Atrial Fibrillation Paroxysmal
Treatment ECG/PPG monitoring
Clinical Study IdentifierNCT05333380
SponsorBeijing Anzhen Hospital
Last Modified on22 October 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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