Clinical Trial for Evaluating the Effectiveness and Safety of the Pulse Wave-based Atrial Fibrillation and Premature Beat Alert Software
NCT07078071 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 199
Last updated 2025-07-22
Summary
This study aims to validate the efficacy and safety of the Pulse Wave-based Atrial Fibrillation and Premature Beat Alert Software (Huawei Device Co., Ltd.). This software can provide alerts, store and display PPG data transmitted from smartwatches or fitness trackers. The software is limited to alerting of atrial fibrillation and premature beat, and the results are only for clinical reference.
Conditions
- Arrhythmia, Heart
Interventions
- DEVICE
-
ECG
Each participant undergoes testing with both the investigation device and the control device simultaneously. The results of the investigation device, which are obtained through pulse wave data analysis at the wrist, are compared to the investigator's interpretation of the ECG.
Sponsors & Collaborators
-
Huawei Device Co., Ltd
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-10-18
- Primary Completion
- 2023-03-01
- Completion
- 2023-03-01
Countries
- China
Study Locations
More Related Trials
-
Validation Study of the Watch HWA09 and Its Softwares ECG-SW1 and PPG-SW1 for the Detection of Atrial Fibrillation
NCT04351386 ·Status: COMPLETED
-
Validation of Software for Assessment of Atrial Fibrillation From PPG Data Acquired by a Wearable Smartwatch
NCT04380415 ·Status: COMPLETED ·Phase: NA
-
Utility of At-home Monitoring of Exercise Capacity by App-based 6-minute Walk Test
NCT03893500 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Determine AF Burden With PPG Trial - Detection and Quantification of Episodes of Atrial Fibrillation
NCT04563572 ·Status: COMPLETED ·Phase: NA
-
Accuracy of Rhythm Detection by a Wearable Smart Watch for Cardiac Arrhythmias (The WATCH-RHYTHM Study)
NCT04499807 ·Status: TERMINATED ·Phase: NA
-
Clinical Performance of Withings Move ECG Software for Atrial Fibrillation Detection
NCT04493749 ·Status: ACTIVE_NOT_RECRUITING
-
Detection and Quantification of Atrial Fibrillation in High-risk Patients Using a Smartwatch Wearable (Apple Watch)
NCT05686330 ·Status: COMPLETED ·Phase: NA
-
Wearable Devices Empowering Active Health Initiatives for High-Risk Stroke Populations
NCT06935513 ·Status: RECRUITING ·Phase: NA
-
Estimation of Average and Beat-to-beat Heart Rate With a Novel Wrist-worn PPG Device in Surgery Patients
NCT03081793 ·Status: COMPLETED
-
Validation of Software for Assessment of Atrial Fibrillation From Data Acquired by a Wearable Smartwatch
NCT04176926 ·Status: COMPLETED
-
A Wearable With Photoplethysmography and 6-lead Electrocardiography for Atrial Fibrillation Detection
NCT04281927 ·Status: COMPLETED
-
Wearable ECG for AF Screening and Stroke Risk Assessment
NCT06907264 ·Status: NOT_YET_RECRUITING
-
Accuracy of Commercially Available Heart Rate Monitors in Athletes
NCT03612063 ·Status: COMPLETED ·Phase: NA
-
Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke
NCT03761394 ·Status: COMPLETED ·Phase: NA
-
Smartwatch Paroxysmal Arrhythmia Detection Compared with Holter
NCT06425887 ·Status: RECRUITING
-
Accuracy of Cardiac Wearables Devices to Detect Atrial Fibrillation
NCT04809922 ·Status: COMPLETED
-
WHOOP ECG Software Performance Assessment Study
NCT06622265 ·Status: COMPLETED
-
Smart Watch, Heart Rate and So2 in Chronic Patients
NCT05271864 ·Status: COMPLETED
-
Use of the ECG Watch in Palpitation Assessment: Feasibility Study
NCT07121816 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Wearable Assessment of Thoracic, Cardiac Health and Exercise Performance Trial
NCT06671171 ·Status: COMPLETED
-
A Wearable EducAtional Intervention to REduce Angina
NCT03134105 ·Status: WITHDRAWN ·Phase: NA
-
A Home Telemonitoring System for Wearable Fetal-ECG and EHG Acquisition During Pregnancy
NCT06031142 ·Status: COMPLETED
-
Atrial Fibrillation Detection Using Garmin Wearable Technology
NCT03566836 ·Status: UNKNOWN
-
Digital Assessment of Real-World Walking Activity in Pulmonary Hypertension: A Prospective Multicenter Trial
NCT07137260 ·Status: RECRUITING
-
Withings ECG-app Study
NCT05316350 ·Status: COMPLETED ·Phase: NA