Withings ECG-app Study

• ClinicalTrials.gov Identifier: NCT05316350
• Recruitment Status: Recruiting
• First Posted: April 7, 2022
• Last Update Posted: January 27, 2023
• Sponsor: Withings
• Collaborator: Syntactx
• Information provided by (Responsible Party): Withings

Tracking Information

• First Submitted Date: March 18, 2022
• First Posted Date: April 7, 2022
• Last Update Posted Date: January 27, 2023
• Actual Study Start Date: July 15, 2022
• Estimated Primary Completion Date: June 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 30, 2022)

• Co-primary outcomes [ Time Frame: 4 months ]
  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.
• Co-primary outcomes [ Time Frame: 4 months ]
  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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 30, 2022)

• Evaluation of the classification into heart rate subgroups [ Time Frame: 4 months ]
  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
• Clinical Equivalence of ECG waveforms [ Time Frame: 4 months ]
  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),
• Clinical Equivalence of ECG waveforms [ Time Frame: 4 months ]
  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.
• Heart Rate equivalence [ Time Frame: 4 months ]
  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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Withings ECG-app Study
• Official Title: Validation of HWA10 With Withings ECG-app for the Detection of Atrial Fibrillation
• Brief 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
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Atrial Fibrillation

Intervention

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

Study Arms

• Experimental: Atrial Fibrillation
  Interventions:

  • Device: Electrocardiogram recording
  • Device: Electrocardiogram recording
• Experimental: Normal Sinus Rhythm
  Interventions:

  • Device: Electrocardiogram recording
  • Device: Electrocardiogram recording

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 30, 2022): 632
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2023
• Estimated Primary Completion Date: June 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 22 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: David Campo, PhD; +33 1.41.46.04.60; david.campo@withings.com

• Listed Location Countries: France, United States

Administrative Information

• NCT Number: NCT05316350
• Other Study ID Numbers: HWA10-ECG
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Withings
• Original Responsible Party: Same as current
• Current Study Sponsor: Withings
• Original Study Sponsor: Same as current
• Collaborators: Syntactx

Investigators

• Principal Investigator: Jeffrey Wessler, MD; Heartbeat Health

• PRS Account: Withings
• Verification Date: January 2023