TerminatedNot Applicable

Accuracy of Rhythm Detection by a Wearable Smart Watch for Cardiac Arrhythmias (The WATCH-RHYTHM Study)

Stopped: Stopped because after we started enrolling we realized that we could not get the information that we wanted out of the current protocol. The information we wanted to compare would not be able to be collected.

United States16 participantsStarted 2021-01-06

Plain-language summary

It is an attempt to see the reliability of the Wearable Smart Watch in identifying atrial fibrillation and other arrhythmias compared to the data detected from ILRs.

Who can participate

Age range

18 Years – 80 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: * Age over 18 years old * Patients who have an implantable loop recorder for heart rhythm monitoring purposes * Having IOS iphone device that can be integrated into Apple Watch * Willing to sign a consent form and participate in the study Exclusion Criteria: * Hemodynamically unstable patients * Over 90 years of age * Presence of wrist tattoos * Presence of AV fistula on the wrist on which the wearable is worn. (If the contralateral wrist is unaffected, those patients can be included) * Presence of Implantable Cardiac Pacemaker and/or ICD * Patients with Parkinsons disease or tremors

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

AFib detection with heart rate data measured by Smart Watch

Timeframe: 5 months

Trial details

NCT IDNCT04499807

SponsorKansas City Heart Rhythm Research Foundation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-03-16

View on ClinicalTrials.gov More Atrial Fibrillation trials

Who can participate

Age range

18 Years – 80 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.