Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05316350
Other study ID # HWA10-ECG
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 15, 2022
Est. completion date August 15, 2023

Study information

Verified date March 2024
Source Withings
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to evaluate the performance of Withings HWA10 with embedded Withings ECG-app in the automatic detection of atrial fibrillation


Recruitment information / eligibility

Status Completed
Enrollment 685
Est. completion date August 15, 2023
Est. primary completion date August 15, 2023
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility Inclusion Criteria: - Male or female who are 22 years of age or older - Subject able to read, understand, and provide written informed consent - Subject willing and able to participate in the study procedures as described in the consent form - Subject able to communicate effectively with and willing to follow instructions from the study staff - Have a wrist circumference between 140 mm and 210 mm (measured at "band center" on the preferred wrist, 1cm from the bone. This location is determined by asking the volunteer to put on a normal wrist-watch and marking the skin with a pen/marker to outline the edges of the band.) Exclusion Criteria: - Vulnerable subject with regard to regulations in force - Subject who is deprived of liberty by judicial, medical or administrative decision, - Underage subject, - Legally protected subject, or subject who is unable, linguistic or psychic incapacity, to sign the written informed consent form, - Subject within several of the above categories, - Subject who refused to participate in the study, - Subject mentally impaired resulting in limited ability to cooperate - Subject in physical incapacity to wear a watch on one wrist and place the other hand on top of the watch - Subject with electrical stimulation by pacemaker - Patient with pathologic disorder that may affect motricity resulting in significant tremor that prevents subject from being able to hold still (e.g Parkinson disease) - Acute myocardial infarction (MI) within 90 days of screening or other cardiovascular disease that, in the opinion of the Investigator, may increase the risk to the subject or renders data uninterpretable (e.g., recent or ongoing unstable angina, decompensated heart failure, active myocarditis or pericarditis) - Acute pulmonary embolism or pulmonary infarction, within 90 days of screening - Stroke or transient ischemic attack within 90 days of screening - Active life-threatening rhythms as determined by the investigator (ventricular tachycardia, ventricular fibrillation, 3 rd -degree heart block). - History of abnormal life-threatening rhythms (ventricular tachycardia, ventricular fibrillation, 3 rd -degree heart block) - Symptomatic (or active) allergic skin reactions such as eczema, rosacea, impetigo, dermatomyositis or allergic contact dermatitis on both wrists or over electrode attachment sites - Known sensitivity to medical adhesives, isopropyl alcohol, watch bands, or electrocardiogram (ECG) electrodes including known allergy or sensitivity to fluoroelastomer bands primarily used in wrist worn fitness devices

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Electrocardiogram recording
ECG recording with investigational device
Electrocardiogram recording
ECG recording with reference device

Locations

Country Name City State
France Henri-Mondor Hospital Créteil Île De France
United States Cambridge Medical Trials Alexandria Louisiana
United States FWD Clinical Research Boca Raton Florida
United States Florida Cardiovascular Research Hialeah Florida
United States Texas Heart Institute Houston Texas
United States American Institute of Therapeutics Lake Bluff Illinois
United States Diverse Clinical Research Miami Florida
United States The Angel Medical Research Miami Lakes Florida
United States Heartbeat Health New York New York
United States LINQ Research LLC Pearland Texas

Sponsors (2)

Lead Sponsor Collaborator
Withings Syntactx

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Co-primary outcomes Sensitivity (percentage of true positives) in detecting AF from conclusive recordings generated by the software under test, that is recordings resulting in a classification of AF or SR by the SUT, compared to the reference 12-lead ECG. 4 months
Primary Co-primary outcomes Specificity (percentage of true negatives) in detecting AF from conclusive recordings generated by the software under test, that is recordings resulting in a classification of AF or SR by the SUT, compared to the reference 12-lead ECG. 4 months
Secondary Evaluation of the classification into heart rate subgroups The classification into heart rate subgroups will be evaluated for the pairs of strips such that the rhythm classification of the 12-lead ECG is either SR or AF and such that the strip generated by the SUT is classified as either SR or AF. The evaluation will be assessed with the concordance of classifications, i.e. the percentage P of identical classifications by the SUT and the reference method, into each of the four following subgroups:
SR with a HR between 50 and 99 bpm
SR with a HR between 100 and 150 bpm
AF with a HR between 50 and 99 bpm
AF with a HR between 100 and 150 bpm
4 months
Secondary Clinical Equivalence of ECG waveforms Clinical Equivalence of ECG waveforms will be qualitatively and quantitatively assessed between the 6-leads generated by the SUT and the leads I, II, III, aVR, aVL, aVF of the 12-lead ECG by a board of certified cardiologists:
The visibility and polarity of the P waves, QRS complexes and T waves will be determined by cardiologists and according to a set of predetermined rules. For each type of wave (P, QRS and T),
4 months
Secondary Clinical Equivalence of ECG waveforms The durations of the QT intervals, QRS complex widths, and PR intervals will be measured by cardiologists with a caliper and according to a set of predetermined rules for each of the 6 leads of the strips generated by the SUT and the leads I, II, III, aVR, aVL, aVF of the 12-lead ECG. 4 months
Secondary Heart Rate equivalence heart rate will be determined by independent cardiologists, or cardiac technicians supervised by cardiologists, from each six-channel strip recorded with the SUT and from each lead I, II, III, aVR, aVL, aVF of the 12-lead reference ECG 4 months
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Terminated NCT04115735 - His Bundle Recording From Subclavian Vein
Completed NCT04571385 - A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF) Phase 2
Completed NCT05366803 - Women's Health Initiative Silent Atrial Fibrillation Recording Study N/A
Completed NCT02864758 - Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
Recruiting NCT05442203 - Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease N/A
Completed NCT05599308 - Evaluation of Blood Pressure Monitor With AFib Screening Feature N/A
Completed NCT03790917 - Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
Enrolling by invitation NCT05890274 - Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO N/A
Recruiting NCT05316870 - Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation N/A
Recruiting NCT05266144 - Atrial Fibrillation Patients Treated With Catheter Ablation
Not yet recruiting NCT06023784 - The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Recruiting NCT04092985 - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed NCT04087122 - Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures N/A
Completed NCT06283654 - Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
Recruiting NCT05416086 - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study N/A
Completed NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)
Completed NCT04546763 - Study Watch AF Detection At Home
Completed NCT03761394 - Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke N/A