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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

266 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-29

Study Completion Date

2023-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Validation of the Electrocardiogram Measurement

NCT05830578

Atrial Fibrillation

UNKNOWN

Atrial Fibrillation Screening With a Smartphone Device and iECG Application

NCT02534532

Atrial Fibrillation

WITHDRAWN

Specific Electrophenotypes in Atrial Fibrillation

NCT05366530

Atrial Fibrillation

ACTIVE_NOT_RECRUITING

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

NCT04519190

Atrial Fibrillation

UNKNOWN

Screening for Atrial Fibrillation Among Older Patients in Primary Care Clinics

NCT03515057

Atrial Fibrillation

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation Atrial Fibrillation Paroxysmal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No