Actions Elicited by In-hospital Follow-up of Cardiac Devices (ATHENS)
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|ClinicalTrials.gov Identifier: NCT01073449|
Recruitment Status : Completed
First Posted : February 23, 2010
Results First Posted : February 28, 2011
Last Update Posted : February 28, 2011
This study will enroll all patients who will attend an in-hospital follow-up of cardiac device since February 22nd 2010 to June 21st 2010.
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.
|Condition or disease||Intervention/treatment|
|Cardiac Pacemaker, Artificial Implantable Cardioverter-Defibrillator||Procedure: In-hospital follow-up of cardiac device|
Number of Pacemakers (PM) and Implantable Cardioverter Defibrillators (ICD) is rapidly growing due to enlarged indications. This fact causes an exponential increase in scheduled in-hospital follow-ups. For this reason, all the companies that produce PM and ICD have released systems that allow remote monitoring and follow-up of cardiac devices (both PM and ICD) and U.S. guidelines have already been changed, in order to suggest remote follow-up of these devices at appropriated intervals.
Nevertheless, informations on actions taken during scheduled in-hospital follow-up are incomplete.
ATHENS study has been designed to answer to 3 questions:
- How often, during a scheduled in hospital follow-up physicians "change" something ? (device programming; drug therapy; scheduled device replacement ...)
- 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?
- Change are more frequent during PM or during ICD follow-up or during cardiac resynchronization therapy devices?
|Study Type :||Observational|
|Actual Enrollment :||3362 participants|
|Official Title:||Action Elicited By Scheduled In-Hospital Follow-Up of Cardiac Devices|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
All patients implanted with a cardiac device, pacemaker(PM)or Implantable Cardioverter Defibrillator (ICD)
Procedure: In-hospital follow-up of cardiac device
Electrical measures taken during normal follow-up and clinical status of the patient
- Number of Patients of the Whole Population in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up [ Time Frame: 4 months ]
- Number of Patients -Amongst Those Implanted With a Pacemaker - in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up [ Time Frame: 4 months ]
- Number of Patients - Amongst Those Implanted With an Implantable Cardioverter Defibrillator (ICD)- in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up [ Time Frame: 4 months ]
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): NCT01073449
|Laboratorio di Elettrofisiologia|
|Desenzano del Garda, Brescia, Italy, 25015|
|Laboratorio di Cardiologia - Ospedale Civile|
|Casalmaggiore, Cremona, Italy, 26041|
|Laboratorio di Elettrofisiologia|
|Merate, Lecco, Italy, 23807|
|U.O. Aritmologia - Cliniche Humanitas Gavazzeni|
|Bergamo, Italy, 24121|
|Laboratorio di Elettrofisiologia - Spedali Civili|
|Brescia, Italy, 25123|
|Laboratorio di Elettrofisiologia - Ospedale A. Manzoni|
|Lecco, Italy, 23900|
|Laboratorio di Elettrofisiologia - Ospedale Carlo Poma|
|Mantova, Italy, 46100|
|Laboratorio di Elettrofisiologia - Ospedale San Matteo|
|Pavia, Italy, 27100|
|Study Chair:||Giosue Mascioli, MD||Cliniche Humanitas Gavazzeni|
|Study Chair:||Antonio Curnis, MD||Spedali Civili di Brescia|
|Principal Investigator:||Maurizio Landolina, MD||Policlinico San Matteo Pavia|
|Principal Investigator:||Gian-Paolo Gelmini, MD||Ospedale Civile di Desenzano d/Garda|
|Principal Investigator:||Franco Ruffa, MD||Ospedale A. Manzoni - Lecco|