Actions Elicited by In-hospital Follow-up of Cardiac Devices (ATHENS)
|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|
|Primary Completion Date :||January 2011|
|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 ]
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|