NCT06686940

Brief Summary

The purpose of this study is to evaluate the monitoring effect of a smart electrocardiogram watch based on the PPG algorithm on atrial fibrillation burden.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
104mo left

Started Dec 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Dec 2024Dec 2034

First Submitted

Initial submission to the registry

November 12, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 13, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

December 30, 2024

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2034

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2034

Last Updated

November 13, 2024

Status Verified

November 1, 2024

Enrollment Period

10 years

First QC Date

November 12, 2024

Last Update Submit

November 12, 2024

Conditions

Atrial Fibrillation (AF)

Keywords

atrial fibrillation burdenPhotoplethysmographyWearable devices.

Outcome Measures

Primary Outcomes (1)

  • Primary outcome

    all-cause death, cardiovascular death, myocardial infarction, heart failure, stroke, peripheral vascular disease, recurrence of atrial fibrillation diagnosed by electrocardiogram, palpitations symptoms

    December 30, 2024 to Decemberr 30, 2034

Interventions

intervention groupDEVICE

The monitoring effect of a smart electrocardiogram watch based on the PPG algorithm on atrial fibrillation burden.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with atrial fibrillation who meet age and health criteria can use electrocardiographic watches for long-term monitoring.

You may qualify if:

  • Atrial fibrillation patients diagnosed by electrocardiogram
  • Willing to use long-range electrocardiogram monitoring equipment

You may not qualify if:

  • Patients who are allergic to electronic devices or unable to wear watches

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100000, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Photoplethysmography data、Electrocardiogram data

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Song Zuo, M.D

CONTACT

1880142775song_zuo@126.com

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

November 12, 2024

First Posted

November 13, 2024

Study Start

December 30, 2024

Primary Completion (Estimated)

December 30, 2034

Study Completion (Estimated)

December 30, 2034

Last Updated

November 13, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)