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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.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dhanunjaya Lakkireddy | Kansas City Heart Rhythm Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kansas City Heart Rhythm Institute | Overland Park | Kansas | 66211 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19932788 | Background | 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. | |
| 23831166 | 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. |
| Label | URL |
|---|---|
| Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised) | View source |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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|
| 18383050 | Background | Savelieva I, Camm J. Update on atrial fibrillation: part II. Clin Cardiol. 2008 Mar;31(3):102-8. doi: 10.1002/clc.20136. |
| 19843914 | 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. |
| 27567408 | 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. |
| 29048522 | 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. |
| 22441062 | 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. |
| 19104573 | 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. |
| 26391728 | 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. |
| 23220686 | 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. |
| 31722151 | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |