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

October 13, 2022 updated by: Chang sheng Ma, Beijing Anzhen Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

266

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Anzhen Hospital
        • Principal Investigator:
          • Song Zuo, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with atrial fibrillation who were hospitalized in the Department of Cardiology, Beijing Anzhen Hospital, aged from 18 to 80,were included in the study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The AF burden calculated from PPG data is compared with that from ECG monitoring.
Time Frame: 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.
Two months after enrollment of the first subject

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Anzhen Hospital

Collaborators

Heart Health Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2022

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

April 1, 2022

First Submitted That Met QC Criteria

April 10, 2022

First Posted (Actual)

April 19, 2022

Study Record Updates

Last Update Posted (Actual)

October 14, 2022

Last Update Submitted That Met QC Criteria

October 13, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-PPG-AF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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