Clinical trial NCT01073449: Actions Elicited by In-hospital Follow-up of Cardiac Devices
Official title: Action Elicited By Scheduled In-Hospital Follow-Up of Cardiac Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Pacemaker, Artificial
Implantable Cardioverter-Defibrillator
Keywords: Cardiac devices
In-Hospital Follow-up
Analytical
Lead sponsor: Cliniche Humanitas Gavazzeni
Sponsor class: OTHER
First posted: 2010-02-23
Enrollment: 3362
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who will undergo an in-hospital follow-up of a cardiac device

Brief summary: 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.

Detailed description: 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:

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?

Eligibility criteria: Inclusion Criteria:

* All patients with a cardiac device

Exclusion Criteria:

* Follow-up of a cardiac device at discharge from hospital after first implant

Primary outcomes:
measure: Number of Patients of the Whole Population in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up
timeFrame: 4 months
Secondary outcomes:
measure: Number of Patients -Amongst Those Implanted With a Pacemaker - in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up
timeFrame: 4 months
measure: 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
timeFrame: 4 months
Other outcomes:
Locations:
city: Desenzano del Garda
country: Italy
facility: Laboratorio di Elettrofisiologia
state: Brescia
city: Casalmaggiore
country: Italy
facility: Laboratorio di Cardiologia - Ospedale Civile
state: Cremona
city: Merate
country: Italy
facility: Laboratorio di Elettrofisiologia
state: Lecco
city: Bergamo
country: Italy
facility: U.O. Aritmologia - Cliniche Humanitas Gavazzeni
city: Brescia
country: Italy
facility: Laboratorio di Elettrofisiologia - Spedali Civili
city: Lecco
country: Italy
facility: Laboratorio di Elettrofisiologia - Ospedale A. Manzoni
city: Mantova
country: Italy
facility: Laboratorio di Elettrofisiologia - Ospedale Carlo Poma
city: Pavia
country: Italy
facility: Laboratorio di Elettrofisiologia - Ospedale San Matteo
Study officials:
affiliation: Cliniche Humanitas Gavazzeni
name: Giosue Mascioli, MD
role: STUDY_CHAIR
affiliation: Spedali Civili di Brescia
name: Antonio Curnis, MD
role: STUDY_CHAIR
affiliation: Policlinico San Matteo Pavia
name: Maurizio Landolina, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale Civile di Desenzano d/Garda
name: Gian-Paolo Gelmini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale A. Manzoni - Lecco
name: Franco Ruffa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.