Accuracy of Cardiac Wearables Devices to Detect Atrial Fibrillation (NCT04809922) | Clinical Trial Compass
CompletedNot Applicable
Accuracy of Cardiac Wearables Devices to Detect Atrial Fibrillation
Switzerland312 participantsStarted 2021-04-06
Plain-language summary
Atrial fibrillation (AF) is the most common cardiac arrhythmia. This study is to assess the heart rhythm device accuracy of five cardiac wearable devices (Apple Watch, Kardia Mobile/Kardia Mobile 6L, Fitbit Sense, Samsung Galaxy Watch 3 and Withings Scanwatch, Withings SA, Model Number: HWA09) and its detection algorithms in identifying AF compared to a nearly simultaneously acquired physician-interpreted 12-lead ECG in a real world cohort of patients.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All consecutive patients undergoing electrophysiological study, pacemaker or implantable defibrillator (ICD) implantation or electric cardioversion at the University Hospital Basel are eligible for study participation and will be asked to participate
Exclusion Criteria:
* Use of a radial artery graft for coronary artery bypass grafting
* Tattoos located on the skin of the wrist or forearm where wearable device will be placed
* Patients receiving hemodialysis through arteriovenous fistula in the upper extremities
* Patients with inability to communicate and comply with all study requirements
* Patients who refused to participate in the trial
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Heart rhythm device accuracy of cardiac wearable devices
Timeframe: one time assessment at baseline
2
Heart rhythm device accuracy of physician-interpreted iECG