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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06351761
Other study ID # SCT02-ECG
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 2024
Est. completion date March 2025

Study information

Verified date May 2024
Source Withings
Contact David Campo
Phone +33 1.41.46.04.60
Email clinical-trials@withings.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to evaluate the performance of Withings SCT02 with embedded Withings ECG-app in the automatic detection of atrial fibrillation


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 270
Est. completion date March 2025
Est. primary completion date January 2025
Accepts healthy volunteers Accepts Healthy Volunteers
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 Exclusion Criteria: - Subject with an implanted electrical device (i.e. pacemaker, ICD …), whether active or inactive - Pathologic disorders that may affect motricity resulting in significant hands tremor that prevents subject from being able to hold still (e.g. Parkinson disease) - Myocardial Infarction (MI) within 90 days prior to the enrollment - Pulmonary embolism or pulmonary infarction within 90 days prior to the enrollment - Stroke or Transient Ischemic Attack (TIA) within 90 days prior to the enrollment - Active or history of life-threatening rhythms as determined by investigators (e.g. ventricular tachycardia, ventricular fibrillation, 3rd degree heart block) - Any cardiovascular disease that investigators would consider as a risk to subject or renders data uninterpretable (e.g. recent or ongoing unstable angina, decompensated heart failure, active myocarditis or pericarditis) - Active or symptomatic skin disease on Schiller electrode attachment sites or fingertips which would be in contact with BeamO electrodes (e.g. eczema, rosacea, impetigo, dermatomyositis or allergic contact dermatitis) - Known sensitivity to medical adhesives, isopropyl alcohol,, electrocardiogram (ECG) electrodes, including known allergy or sensitivity to stainless steel (used in BeamO electrodes).

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Investigational Device (Withings SCT02) 30 second Electrocardiogram recording
30 second ECG recording with investigational device (Withings SCT02)
Reference Device (Schiller Cardiovit FT-1) 30 second Electrocardiogram recording
30 second ECG recording with reference device (Schiller Cardiovit FT-1)

Locations

Country Name City State
France Henri Mondor University Hospital Créteil Val De Marne
United States FWD Clinical Research Boca Raton Florida
United States Diverse Clinical Research Miami Florida

Sponsors (1)

Lead Sponsor Collaborator
Withings

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Co-primary outcome 1 - Sensitivity of Investigational Device 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 IMD, compared to the reference 12-lead ECG. 10 months
Primary Co-primary outcome 2 - Specificity of Investigational Device 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 IMD, compared to the reference 12-lead ECG. 10 months
Secondary Rhythm classification by ranges of heart rate On 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 IMD is classified as either SR or AF, the classification into four heart rate subgroups will be evaluated.
Sinus Rhythm, (50-99 bpm)
High Heart Rate (No signs of AFib) (100-150 bpm)
Atrial Fibrillation (50-99 bpm),
Atrial Fibrillation (100-150 bpm)
10 months
Secondary Quality of plots measured by the IMD - ECG Waveform Visibility Clinical Equivalence of ECG waveforms will be qualitatively and quantitatively assessed between the 1-lead generated by the IMD and the lead I of the 12-lead reference ECG determined by certified cardiologists. Equivalence will be evaluated by FV : Fraction of concordant assessments of visibility between the IMD and the reference 10 months
Secondary Quality of plots measured by the IMD - ECG Waveforms Polarity On waveforms with waves that are Visible, Clinical Equivalence of ECG waveforms will be qualitatively and quantitatively assessed between the 1-lead generated by the IMD and the lead I of the 12-lead reference ECG determined by certified cardiologists. Equivalence will be evaluated by FP : Fraction of concordant assessment of polarity between IMD and reference 10 months
Secondary Quality of plots measured by the IMD - ECG Waveforms Intervals Determine the equivalence of PR, QRS and QT intervals durations between the lead I of the IMD and the lead I of the reference ECG determined by an independent board of certified cardiologists. Duration error will be calculated. 10 months
Secondary Quality of plots measured by the IMD - Heart Rate calculation Determine the equivalence of the heart rate (HR) calculated by the IMD and the HR measured by an independent board of certified cardiologists or cardiology technicians on the ECG of the reference. 10 months
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