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

NCT04499807 | Terminated

• 1 other identifier: KCHRF-WATCH RHYTHM-0006
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation

Keywords

Wearable technology; Smart Watch; ILR; AFib detection

Outcome Measures

Primary Outcomes (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.

  5 months

Study Arms (1)

Smart Watch

OTHER

The patients will wear the Smart Watch to generate data to assess their rhythm as confirmed by the ILR done during the same time.

Other: AFib detection with wearable smart watch

Interventions

AFib detection with wearable smart watch OTHER

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.

Smart Watch

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kansas City Heart Rhythm Research Foundation: lead

Study Sites (1)

Kansas City Heart Rhythm Institute

Overland Park, Kansas, 66211, United States

Location

Related Publications (11)

• 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.

  PMID: 19932788 BACKGROUND

• 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.

  PMID: 23831166 BACKGROUND

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

  PMID: 18383050 BACKGROUND

• 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.

  PMID: 19843914 BACKGROUND

• 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.

  PMID: 27567408 BACKGROUND

• 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.

  PMID: 29048522 BACKGROUND

• 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.

  PMID: 22441062 BACKGROUND

• 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.

  PMID: 19104573 BACKGROUND

• 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.

  PMID: 26391728 BACKGROUND

• 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.

  PMID: 23220686 BACKGROUND

• 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.

  PMID: 31722151 BACKGROUND

Related Links

• Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dhanunjaya Lakkireddy

  Kansas City Heart Rhythm Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 5, 2020
• Study Start: January 6, 2021
• Primary Completion: March 16, 2021
• Study Completion: March 16, 2021
• Last Updated: March 10, 2023

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)