Actions Elicited by In-hospital Follow-up of Cardiac Devices

Cardiac Pacemaker, Artificial Clinical Trial

— ATHENS  

Official title:

Action Elicited By Scheduled In-Hospital Follow-Up of Cardiac Devices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01073449
• Other study ID #: GAVBS1
• Status: Completed
• Phase: N/A
• First received: February 22, 2010
• Last updated: February 2, 2011
• Start date: February 2010
• Est. completion date: January 2011

Study information

• Verified date: January 2011
• Source: Cliniche Humanitas Gavazzeni
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3362
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients with a cardiac device

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Pacemaker, Artificial
• Implantable Cardioverter-Defibrillator

Intervention

Procedure:
• In-hospital follow-up of cardiac device
Electrical measures taken during normal follow-up and clinical status of the patient

Locations

Country	Name	City	State
Italy	U.O. Aritmologia - Cliniche Humanitas Gavazzeni	Bergamo
Italy	Laboratorio di Elettrofisiologia - Spedali Civili	Brescia
Italy	Laboratorio di Cardiologia - Ospedale Civile	Casalmaggiore	Cremona
Italy	Laboratorio di Elettrofisiologia	Desenzano del Garda	Brescia
Italy	Laboratorio di Elettrofisiologia - Ospedale A. Manzoni	Lecco
Italy	Laboratorio di Elettrofisiologia - Ospedale Carlo Poma	Mantova
Italy	Laboratorio di Elettrofisiologia	Merate	Lecco
Italy	Laboratorio di Elettrofisiologia - Ospedale San Matteo	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
Cliniche Humanitas Gavazzeni

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients of the Whole Population in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up		4 months	Yes
Secondary	Number of Patients -Amongst Those Implanted With a Pacemaker - in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up		4 months	No
Secondary	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		4 months	No