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

Primary Purpose

Atrial Fibrillation

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AFib detection with wearable smart watch
Sponsored by
Kansas City Heart Rhythm Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Atrial Fibrillation focused on measuring Wearable technology, Smart Watch, ILR, AFib detection

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kansas City Heart Rhythm Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Smart Watch

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 29, 2020
Last Updated
March 8, 2023
Sponsor
Kansas City Heart Rhythm Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04499807
Brief Title
Accuracy of Rhythm Detection by a Wearable Smart Watch for Cardiac Arrhythmias (The WATCH-RHYTHM Study)
Official Title
Accuracy of Rhythm Detection and Managing Data Deluge by a Wearable Smart Watch for Cardiac Arrhythmias (The WATCH-RHYTHM Study)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why 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.
Study Start Date
January 6, 2021 (Actual)
Primary Completion Date
March 16, 2021 (Actual)
Study Completion Date
March 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kansas City Heart Rhythm Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Wearable technology, Smart Watch, ILR, AFib detection

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Smart Watch
Arm Type
Other
Arm Description
The patients will wear the Smart Watch to generate data to assess their rhythm as confirmed by the ILR done during the same time.
Intervention Type
Other
Intervention Name(s)
AFib detection with wearable smart watch
Intervention Description
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.
Primary Outcome Measure Information:
Title
AFib detection with heart rate data measured by Smart Watch
Description
Heart rate data generated by Smart Watch is used to assess their rhythm as confirmed by the ILR done during the same time.
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dhanunjaya Lakkireddy
Organizational Affiliation
Kansas City Heart Rhythm Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kansas City Heart Rhythm Institute
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19932788
Citation
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.
Results Reference
background
PubMed Identifier
23831166
Citation
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.
Results Reference
background
PubMed Identifier
18383050
Citation
Savelieva I, Camm J. Update on atrial fibrillation: part II. Clin Cardiol. 2008 Mar;31(3):102-8. doi: 10.1002/clc.20136.
Results Reference
background
PubMed Identifier
19843914
Citation
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.
Results Reference
background
PubMed Identifier
27567408
Citation
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.
Results Reference
background
PubMed Identifier
29048522
Citation
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. Erratum In: Europace. 2018 Apr 1;20(4):658.
Results Reference
background
PubMed Identifier
22441062
Citation
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.
Results Reference
background
PubMed Identifier
19104573
Citation
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.
Results Reference
background
PubMed Identifier
26391728
Citation
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.
Results Reference
background
PubMed Identifier
23220686
Citation
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.
Results Reference
background
PubMed Identifier
31722151
Citation
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.
Results Reference
background
Links:
URL
https://www.fda.gov/media/136290/download
Description
Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)

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

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