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Withings ECG-app Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05316350
Recruitment Status : Recruiting
First Posted : April 7, 2022
Last Update Posted : January 27, 2023
Sponsor:
Collaborator:
Syntactx
Information provided by (Responsible Party):
Withings

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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: Electrocardiogram recording Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 632 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Validation of HWA10 With Withings ECG-app for the Detection of Atrial Fibrillation
Actual Study Start Date : July 15, 2022
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Atrial Fibrillation Device: Electrocardiogram recording
ECG recording with investigational device

Device: Electrocardiogram recording
ECG recording with reference device

Experimental: Normal Sinus Rhythm Device: Electrocardiogram recording
ECG recording with investigational device

Device: Electrocardiogram recording
ECG recording with reference device




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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),


  3. 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.

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05316350


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

Locations
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United States, Florida
FWD Clinical Research Recruiting
Boca Raton, Florida, United States, 33486
Contact: Esthefany Jabbour       esthefany@fwdclinical.com   
Principal Investigator: Michael Cammarata, MD         
Florida Cardiovascular Research Recruiting
Hialeah, Florida, United States, 33012
Contact: Study Coordinator       ketia@floridavresearch.com   
Principal Investigator: Pablo Guala, MD         
The Angel Medical Research Recruiting
Miami Lakes, Florida, United States, 33016
Contact: Study Coordiator       leadcoordinator@theangelresearch.com   
Principal Investigator: John Dylewski, MD         
United States, Illinois
American Institute of Therapeutics Recruiting
Lake Bluff, Illinois, United States, 60044
Contact: John Somberg, MD       johnsomberg1@comcast.net   
Principal Investigator: John Somberg, MD         
United States, Louisiana
Cambridge Medical Trials Recruiting
Alexandria, Louisiana, United States, 71301
Contact: Naseem Jaffrani, MD         
Principal Investigator: Naseem Jaffrani, MD         
United States, New York
Heartbeat Health Recruiting
New York, New York, United States, 10019
Contact: Jeffrey Wessler, MD         
Contact: Study Coordinator       clinical@heartbeathealth.com   
Principal Investigator: Jeffrey Wessler, MD         
United States, Texas
Texas Heart Institute Recruiting
Houston, Texas, United States, 77030
Contact: Study Coordinator       hpetaway@texasheart.org   
Principal Investigator: Brianna Costello, MD         
LINQ Research LLC Recruiting
Pearland, Texas, United States, 77584
Contact: Study Coordinator, MD    281-984-4358      
Principal Investigator: Andres Vasquez, MD         
France
Henri-Mondor Hospital Recruiting
Créteil, Île De France, France, 94000
Contact: Jean-Pascal Lefaucheur, Pr    + 33 (0)1 49 81 26 77    jean-pascal.lefaucheur@aphp.fr   
Sponsors and Collaborators
Withings
Syntactx
Investigators
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Principal Investigator: Jeffrey Wessler, MD Heartbeat Health
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Responsible Party: Withings
ClinicalTrials.gov Identifier: NCT05316350    
Other Study ID Numbers: HWA10-ECG
First Posted: April 7, 2022    Key Record Dates
Last Update Posted: January 27, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Withings:
mhealth
Atrial Fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes