A Novel Healthcare Information Technology Tool to Improve Care in Patients With Atrial Fibrillation

NCT02623517 | Completed

• 1 other identifier: 150702
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with implantable heart devices including pacemakers, defibrillators, and cardiac monitors may not seek regular medical care related to their implanted devices. These devices are capable of detecting abnormal heart rhythms or other device abnormalities that may benefit from clinical action or oversight. A novel healthcare information technology has been developed and is being implemented clinically for screening of patients with cardiac rhythm devices who seek care in the emergency room setting. This study seeks to examine differences in detection of cardiac rhythm disturbances including atrial fibrillation (AF) with utilization of this new screening technology, and how often treatment plans change in patients who have a heart rhythm abnormality detected.

Conditions

Atrial Fibrillation

Keywords

CIED; AF; arrhythmia; atrial fibrillation; cardiac device; pacemaker; defibrillator

Outcome Measures

Primary Outcomes (7)

• The prevalence of atrial fibrillation in patients with CIEDs

  To establish the prevalence of device detected atrial tachyarrhythmia episodes (most commonly AF) in patients who have device interrogations performed in the Emergency Room by the Geneva Healthcare Patient Population Management Platform

  two years

• The prevalence of cardiac electrophysiology referrals from the E.D

  To establish the prevalence of cardiac electrophysiology referral in a population of patients with cardiac rhythm devices but no Geneva Healthcare Patient Population Management Platform routine interrogation versus routine interrogation in the emergency room.

  two years

• The patient population with AF that are treated with catheter ablation

  two years

• The patient population with AF that are treated with rate-control therapy

  two years

• The patient population with AF that are treated with rhythm control drug therapy

  two years

• The patient population with AF that are treated with oral anticoagulation for stroke prophylaxis

  two years

• The prevalence of device and lead malfunctions in patients with CIEDs.

  To investigate the prevalence of device and lead malfunction in a population of patients with cardiac rhythm devices undergoing interrogation by the Geneva Healthcare Patient Population Management Platform.

  two years

Study Arms (2)

Enrolled Subjects

The Enrolled Subjects group will comprise of 75 individuals who will be followed for 12 months for their atrial fibrillation condition. Data will be collected from subjects' devices for 12 months, and any needed changes or additions to therapy will be done. (ie: ablation, pacemaker setting changes, medication control).

Registry Subjects

The Registry Subjects group will comprise of screened patients who do not exhibit symptoms of atrial fibrillation at the time of screening. The already collected data from the patient's device during the screening visit will be kept and put into a registry.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with cardiovascular implantable electronic devices (CIED), including pacemakers, defibrillators, and cardiac resynchronization therapy devices

You may qualify if:

• Patients with Atrial Fibrillation
• Patients presented in the UCSD E.D with a CIED
• Patient willingness to participate

You may not qualify if:

• Any medical condition that may prevent patient's ability to participate
• No indication of Atrial Fibrillation
• Patient unable to follow-up at UCSD or follow research instructions

Sponsors & Collaborators

• University of California, San Diego: lead
• Biosense Webster, Inc.: collaborator

Study Sites (1)

Sulpizio Cardiovascular Center

La Jolla, California, 92037, United States

Location

Related Publications (5)

• Lloyd-Jones DM, Wang TJ, Leip EP, Larson MG, Levy D, Vasan RS, D'Agostino RB, Massaro JM, Beiser A, Wolf PA, Benjamin EJ. Lifetime risk for development of atrial fibrillation: the Framingham Heart Study. Circulation. 2004 Aug 31;110(9):1042-6. doi: 10.1161/01.CIR.0000140263.20897.42. Epub 2004 Aug 16.

  PMID: 15313941 RESULT

• Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001 May 9;285(18):2370-5. doi: 10.1001/jama.285.18.2370.

  PMID: 11343485 RESULT

• Healey JS, Connolly SJ, Gold MR, Israel CW, Van Gelder IC, Capucci A, Lau CP, Fain E, Yang S, Bailleul C, Morillo CA, Carlson M, Themeles E, Kaufman ES, Hohnloser SH; ASSERT Investigators. Subclinical atrial fibrillation and the risk of stroke. N Engl J Med. 2012 Jan 12;366(2):120-9. doi: 10.1056/NEJMoa1105575.

  PMID: 22236222 RESULT

• 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 RESULT

• Calkins H, Kuck KH, Cappato R, Brugada J, Camm AJ, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, DiMarco J, Edgerton J, Ellenbogen K, Ezekowitz MD, Haines DE, Haissaguerre M, Hindricks G, Iesaka Y, Jackman W, Jalife J, Jais P, Kalman J, Keane D, Kim YH, Kirchhof P, Klein G, Kottkamp H, Kumagai K, Lindsay BD, Mansour M, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Nakagawa H, Natale A, Nattel S, Packer DL, Pappone C, Prystowsky E, Raviele A, Reddy V, Ruskin JN, Shemin RJ, Tsao HM, Wilber D; Heart Rhythm Society Task Force on Catheter and Surgical Ablation of Atrial Fibrillation. 2012 HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design: a report of the Heart Rhythm Society (HRS) Task Force on Catheter and Surgical Ablation of Atrial Fibrillation. Developed in partnership with the European Heart Rhythm Association (EHRA), a registered branch of the European Society of Cardiology (ESC) and the European Cardiac Arrhythmia Society (ECAS); and in collaboration with the American College of Cardiology (ACC), American Heart Association (AHA), the Asia Pacific Heart Rhythm Society (APHRS), and the Society of Thoracic Surgeons (STS). Endorsed by the governing bodies of the American College of Cardiology Foundation, the American Heart Association, the European Cardiac Arrhythmia Society, the European Heart Rhythm Association, the Society of Thoracic Surgeons, the Asia Pacific Heart Rhythm Society, and the Heart Rhythm Society. Heart Rhythm. 2012 Apr;9(4):632-696.e21. doi: 10.1016/j.hrthm.2011.12.016. Epub 2012 Mar 1. No abstract available.

  PMID: 22386883 RESULT

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

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

Study Officials

• Jonathan Hsu, MD

  UC San Diego School of Medicine; Sulpizio Cardiovascular Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 7, 2015
• Study Start: May 1, 2016
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)