A Study on the Effectiveness of the Application of an Artificial Intelligence Algorithm for Calibrating PPG With ECG to Improve the Accuracy of Atrial Fibrillation Burden Estimation

NCT06552468 | Completed

• 1 other identifier: KS2024008
• Study Type: observational
• Target: 1,054
• Locations: 1 country
• Sites: 1

Brief Summary

Use the ECG watch to collect W-PPG and W-ECG data. Through artificial intelligence algorithms, compare the W-PPG data collected by the ECG watch and the W-PPG data calibrated by the W-ECG data of the ECG watch with the P-ECG data manually annotated after being collected by the ECG recorder. Then evaluate the effectiveness of the calibrated algorithm in improving the accuracy of estimating atrial fibrillation burden.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation Burden、 AI Correction、W-PPG

Outcome Measures

Primary Outcomes (1)

• Automatically analyze the W-PPG data and the W-PPG data calibrated by W-ECG.

  Automatically analyze the W-PPG data and the W-PPG data calibrated by W-ECG through the "Smart-AF" of Xinjikang Company, and then compare the analyzed results with the P-ECG results manually annotated and proofread.

  One day

Secondary Outcomes (1)

• Automatically analyze the W-PPG data and the W-PPG data calibrated by W-ECG.

  One day

Interventions

AF monitoring by a smartwatch with PPG DEVICE

The device we used for intervention is a smartwatch (JKwear 1, Chengdu CVhealth Science and Technology Co., Ltd, CN) for collecting watch-recorded-PPG (W-PPG).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with AF who were hospitalized for AF in the Department of Cardiology, Beijing Anzhen Hospital.

You may qualify if:

• Patients must meet all of the following criteria to be included in the study:
• Aged 18 and above;
• There was a clear electrocardiogram record of atrial fibrillation in the past, and atrial fibrillation ablation surgery will be performed during this hospitalization；
• Patients who agree to wear both the "ECG watch" and the "ECG recorder" simultaneously；

You may not qualify if:

• Patients who meet any of the following criteria cannot be included in this study:
• Unable to complete the wearing due to problems such as limited mobility.
• Severe skin diseases such as severe skin allergies or skin ulcers.
• Those with chronic insomnia who have not received drug treatment.
• Patients with severe cardiovascular and cerebrovascular diseases who may need emergency treatment at any time.
• Those with a history of Parkinson's disease, schizophrenia, or epilepsy.
• Black people and those with overly dark skin.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital

Beijing, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Photoplethysmography data、Electrocardiogram data

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2024
• First Posted: August 14, 2024
• Study Start: January 14, 2024
• Primary Completion: June 27, 2024
• Study Completion: November 27, 2024
• Last Updated: December 31, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)