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Atrial FibrillationNCT04499807

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

A study testing AFib detection with wearable smart watch in people with Atrial Fibrillation, run by Kansas City Heart Rhythm Research Foundation at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Atrial Fibrillation
What is being tested?
AFib detection with wearable smart watch
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
6 Jan 2021to 16 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Kansas City Heart Rhythm Institute

    Overland Park, Kansas, 66211

Other trials in United States

About this study

Official title: Accuracy of Rhythm Detection and Managing Data Deluge by a Wearable Smart Watch for Cardiac Arrhythmias (The WATCH-RHYTHM Study)

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.

Read the detailed description

The sensitivity, specificity, positive and negative predictive values for successful identification of normal sinus rhythm, atrial fibrillation and other rhythm disorders from the smart watch will compared to that of an ILR.

Being tested
AFib detection with wearable smart watch
Keywords
Wearable technology, Smart Watch, ILR, AFib detection
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AFib detection with wearable smart watchOther

    Patients will transmit two rhythm strips every day through both the devices and additional transmission whenever they have symptoms (palpitations, skipped beats, shortness of breath and chest pain). The transmitted rhythm strips are de-identified and analyzed after assigning a unique ID for research purposes.

Study groups in NCT04499807
Study groupRoleWhat they receive
Smart WatchOtherThe patients will wear the Smart Watch to generate data to assess their rhythm as confirmed by the ILR done during the same time.
Receives: Other: AFib detection with wearable smart watch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AFib detection with heart rate data measured by Smart Watch

    Heart rate data generated by Smart Watch is used to assess their rhythm as confirmed by the ILR done during the same time.

    Measured: 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2020
  2. Study start6 Jan 2021
  3. Primary completion16 Mar 2021
  4. Study completion16 Mar 2021

Why it 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04499807
Sponsor's protocol ID
KCHRF-WATCH RHYTHM-0006
Status last verified
Sep 2021
First submitted
29 Jul 2020
Last updated
10 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Naccarelli GV, Varker H, Lin J, Schulman KL. Increasing prevalence of atrial fibrillation and flutter in the United States. Am J Cardiol. 2009 Dec 1;104(11):1534-9. doi: 10.1016/j.amjcard.2009.07.022.

    PubMed 19932788

  • Colilla S, Crow A, Petkun W, Singer DE, Simon T, Liu X. Estimates of current and future incidence and prevalence of atrial fibrillation in the U.S. adult population. Am J Cardiol. 2013 Oct 15;112(8):1142-7. doi: 10.1016/j.amjcard.2013.05.063. Epub 2013 Jul 4.

    PubMed 23831166

  • Savelieva I, Camm J. Update on atrial fibrillation: part II. Clin Cardiol. 2008 Mar;31(3):102-8. doi: 10.1002/clc.20136.

    PubMed 18383050

  • Glotzer TV, Daoud EG, Wyse DG, Singer DE, Ezekowitz MD, Hilker C, Miller C, Qi D, Ziegler PD. The relationship between daily atrial tachyarrhythmia burden from implantable device diagnostics and stroke risk: the TRENDS study. Circ Arrhythm Electrophysiol. 2009 Oct;2(5):474-80. doi: 10.1161/CIRCEP.109.849638. Epub 2009 Aug 4.

    PubMed 19843914

  • Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P; ESC Scientific Document Group. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016 Oct 7;37(38):2893-2962. doi: 10.1093/eurheartj/ehw210. Epub 2016 Aug 27. No abstract available.

    PubMed 27567408

  • Mairesse GH, Moran P, Van Gelder IC, Elsner C, Rosenqvist M, Mant J, Banerjee A, Gorenek B, Brachmann J, Varma N, Glotz de Lima G, Kalman J, Claes N, Lobban T, Lane D, Lip GYH, Boriani G; ESC Scientific Document Group. Screening for atrial fibrillation: a European Heart Rhythm Association (EHRA) consensus document endorsed by the Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS), and Sociedad Latinoamericana de Estimulacion Cardiaca y Electrofisiologia (SOLAECE). Europace. 2017 Oct 1;19(10):1589-1623. doi: 10.1093/europace/eux177. No abstract available.

    PubMed 29048522

  • Stott DJ, Dewar RI, Garratt CJ, Griffith KE, Harding NJ, James MA, Lane DA, Petty DR, Smith PA, Somerville MH, Trueland J. RCPE UK Consensus Conference on 'approaching the comprehensive management of atrial fibrillation: evolution or revolution?'. J R Coll Physicians Edinb. 2012 Mar;42(1):34-5. doi: 10.4997/JRCPE.2012.S01. No abstract available.

    PubMed 22441062

  • Verkruysse W, Svaasand LO, Nelson JS. Remote plethysmographic imaging using ambient light. Opt Express. 2008 Dec 22;16(26):21434-45. doi: 10.1364/oe.16.021434.

    PubMed 19104573

  • McMANUS DD, Chong JW, Soni A, Saczynski JS, Esa N, Napolitano C, Darling CE, Boyer E, Rosen RK, Floyd KC, Chon KH. PULSE-SMART: Pulse-Based Arrhythmia Discrimination Using a Novel Smartphone Application. J Cardiovasc Electrophysiol. 2016 Jan;27(1):51-7. doi: 10.1111/jce.12842. Epub 2015 Nov 13.

    PubMed 26391728

  • McManus DD, Lee J, Maitas O, Esa N, Pidikiti R, Carlucci A, Harrington J, Mick E, Chon KH. A novel application for the detection of an irregular pulse using an iPhone 4S in patients with atrial fibrillation. Heart Rhythm. 2013 Mar;10(3):315-9. doi: 10.1016/j.hrthm.2012.12.001. Epub 2012 Dec 6.

    PubMed 23220686

  • Perez MV, Mahaffey KW, Hedlin H, Rumsfeld JS, Garcia A, Ferris T, Balasubramanian V, Russo AM, Rajmane A, Cheung L, Hung G, Lee J, Kowey P, Talati N, Nag D, Gummidipundi SE, Beatty A, Hills MT, Desai S, Granger CB, Desai M, Turakhia MP; Apple Heart Study Investigators. Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation. N Engl J Med. 2019 Nov 14;381(20):1909-1917. doi: 10.1056/NEJMoa1901183.

    PubMed 31722151

Questions about this trial

What is this clinical trial studying?

A study testing AFib detection with wearable smart watch in people with Atrial Fibrillation, run by Kansas City Heart Rhythm Research Foundation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: 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.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AFib detection with heart rate data measured by Smart Watch (time frame: 5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04499807, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023.

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