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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02623517
Recruitment Status : Completed
First Posted : December 7, 2015
Last Update Posted : August 5, 2022
Sponsor:
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Jonathan Hsu, University of California, San Diego

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.

Condition or disease
Atrial Fibrillation

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Novel Healthcare Information Technology Tool to Improve Care in Patients
Study Start Date : May 2016
Actual Primary Completion Date : July 1, 2021
Actual Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. The prevalence of atrial fibrillation in patients with CIEDs [ Time Frame: two years ]
    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

  2. The prevalence of cardiac electrophysiology referrals from the E.D [ Time Frame: two years ]
    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.

  3. The patient population with AF that are treated with catheter ablation [ Time Frame: two years ]
  4. The patient population with AF that are treated with rate-control therapy [ Time Frame: two years ]
  5. The patient population with AF that are treated with rhythm control drug therapy [ Time Frame: two years ]
  6. The patient population with AF that are treated with oral anticoagulation for stroke prophylaxis [ Time Frame: two years ]
  7. The prevalence of device and lead malfunctions in patients with CIEDs. [ Time Frame: two years ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with cardiovascular implantable electronic devices (CIED), including pacemakers, defibrillators, and cardiac resynchronization therapy devices
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02623517


Locations
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United States, California
Sulpizio Cardiovascular Center
La Jolla, California, United States, 92037
Sponsors and Collaborators
University of California, San Diego
Biosense Webster, Inc.
Investigators
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Principal Investigator: Jonathan Hsu, MD UC San Diego School of Medicine; Sulpizio Cardiovascular Center
Publications of Results:
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.

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Responsible Party: Jonathan Hsu, Assistant Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02623517    
Other Study ID Numbers: 150702
First Posted: December 7, 2015    Key Record Dates
Last Update Posted: August 5, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jonathan Hsu, University of California, San Diego:
CIED
AF
arrhythmia
atrial fibrillation
cardiac device
pacemaker
defibrillator
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes