Actions Elicited by In-hospital Follow-up of Cardiac Devices (ATHENS)

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Pacemaker, Artificial; Implantable Cardioverter-Defibrillator
• Intervention / Treatment: Procedure: In-hospital follow-up of cardiac device

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?

• Study Type: Observational
• Enrollment (Actual): 3362

Contacts and Locations

Study Locations

• Italy
  • Bergamo, Italy, 24121
    • U.O. Aritmologia - Cliniche Humanitas Gavazzeni
  • Brescia, Italy, 25123
    • Laboratorio di Elettrofisiologia - Spedali Civili
  • Lecco, Italy, 23900
    • Laboratorio di Elettrofisiologia - Ospedale A. Manzoni
  • Mantova, Italy, 46100
    • Laboratorio di Elettrofisiologia - Ospedale Carlo Poma
  • Pavia, Italy, 27100
    • Laboratorio di Elettrofisiologia - Ospedale San Matteo
  • Brescia
    • Desenzano del Garda, Brescia, Italy, 25015
      • Laboratorio di Elettrofisiologia
  • Cremona
    • Casalmaggiore, Cremona, Italy, 26041
      • Laboratorio di Cardiologia - Ospedale Civile
  • Lecco
    • Merate, Lecco, Italy, 23807
      • Laboratorio di Elettrofisiologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients who will undergo an in-hospital follow-up of a cardiac device

Description

Inclusion Criteria:

• All patients with a cardiac device

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cardiac device; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Patients of the Whole Population in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up	4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Cliniche Humanitas Gavazzeni
• Investigators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: February 22, 2010
• First Submitted That Met QC Criteria: February 22, 2010
• First Posted (Estimate): February 23, 2010

Study Record Updates

• Last Update Posted (Estimate): February 28, 2011
• Last Update Submitted That Met QC Criteria: February 2, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: Cardiac devices; In-Hospital Follow-up; Analytical
• Other Study ID Numbers: GAVBS1