Actions Elicited by In-hospital Follow-up of Cardiac Devices
NCT ID: NCT01073449
Last Updated: 2011-02-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
3362 participants
OBSERVATIONAL
2010-02-28
2011-01-31
Brief Summary
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Primary objective of the study is to observe how many of patients seen during these period (approximately 5000) will receive a change in cardiac device programming or in drug therapy or a scheduled or urgent hospital admission.
These data should help to clarify how useful and safe is a remote monitoring strategy for this kind of patients.
Detailed Description
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Nevertheless, informations on actions taken during scheduled in-hospital follow-up are incomplete.
ATHENS study has been designed to answer to 3 questions:
1. How often, during a scheduled in hospital follow-up physicians "change" something ? (device programming; drug therapy; scheduled device replacement ...)
2. The "rate of change" is different is the follow-up is required pby the general practitioner who normally takes care of the patients or by the patient itself?
3. Change are more frequent during PM or during ICD follow-up or during cardiac resynchronization therapy devices?
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cardiac device
All patients implanted with a cardiac device, pacemaker(PM)or Implantable Cardioverter Defibrillator (ICD)
In-hospital follow-up of cardiac device
Electrical measures taken during normal follow-up and clinical status of the patient
Interventions
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In-hospital follow-up of cardiac device
Electrical measures taken during normal follow-up and clinical status of the patient
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Cliniche Humanitas Gavazzeni
OTHER
Responsible Party
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Dr. Giosuè Mascioli
Principal Investigators
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Giosue Mascioli, MD
Role: STUDY_CHAIR
Cliniche Humanitas Gavazzeni
Antonio Curnis, MD
Role: STUDY_CHAIR
Spedali Civili di Brescia
Maurizio Landolina, MD
Role: PRINCIPAL_INVESTIGATOR
Policlinico San Matteo Pavia
Gian-Paolo Gelmini, MD
Role: PRINCIPAL_INVESTIGATOR
Ospedale Civile di Desenzano d/Garda
Franco Ruffa, MD
Role: PRINCIPAL_INVESTIGATOR
Ospedale A. Manzoni - Lecco
Locations
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U.O. Aritmologia - Cliniche Humanitas Gavazzeni
Bergamo, Bergamo, Italy
Laboratorio di Elettrofisiologia - Spedali Civili
Brescia, Brescia, Italy
Laboratorio di Elettrofisiologia
Desenzano del Garda, Brescia, Italy
Laboratorio di Cardiologia - Ospedale Civile
Casalmaggiore, Cremona, Italy
Laboratorio di Elettrofisiologia - Ospedale A. Manzoni
Lecco, Lecco, Italy
Laboratorio di Elettrofisiologia
Merate, Lecco, Italy
Laboratorio di Elettrofisiologia - Ospedale Carlo Poma
Mantova, Mantova, Italy
Laboratorio di Elettrofisiologia - Ospedale San Matteo
Pavia, Pavia, Italy
Countries
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References
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Senges-Becker JC, Klostermann M, Becker R, Bauer A, Siegler KE, Katus HA, Schoels W. What is the "optimal" follow-up schedule for ICD patients? Europace. 2005 Jul;7(4):319-26. doi: 10.1016/j.eupc.2005.02.117.
Fauchier L, Sadoul N, Kouakam C, Briand F, Chauvin M, Babuty D, Clementy J. Potential cost savings by telemedicine-assisted long-term care of implantable cardioverter defibrillator recipients. Pacing Clin Electrophysiol. 2005 Jan;28 Suppl 1:S255-9. doi: 10.1111/j.1540-8159.2005.00071.x.
Brugada P. What evidence do we have to replace in-hospital implantable cardioverter defibrillator follow-up? Clin Res Cardiol. 2006;95 Suppl 3:III3-9. doi: 10.1007/s00392-006-1302-x.
Mascioli G, Curnis A, Landolina M, Klersy C, Gelmini GP, Ruffa F; ATHENS Investigators. Actions elicited during scheduled and unscheduled in-hospital follow-up of cardiac devices: results of the ATHENS multicentre registry. Europace. 2011 Dec;13(12):1766-73. doi: 10.1093/europace/eur233. Epub 2011 Jul 14.
Other Identifiers
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GAVBS1
Identifier Type: -
Identifier Source: org_study_id