Withings ECG-app Study
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atrial Fibrillation | Device: Electrocardiogram recording | Not Applicable |
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 |

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 |
- 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.
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 22 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
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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

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
Contact: David Campo, PhD | +33 1.41.46.04.60 | david.campo@withings.com |
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 |
Principal Investigator: | Jeffrey Wessler, MD | Heartbeat Health |
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 |
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 |
mhealth Atrial Fibrillation |
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |