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

Study Overview
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Brief Summary
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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
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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?

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

Conditions
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Cardiac Pacemaker, Artificial, Implantable Cardioverter-Defibrillator

Intervention / Treatment
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* Procedure: In-hospital follow-up of cardiac device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with a cardiac device Exclusion Criteria: Follow-up of a cardiac device at discharge from hospital after first implant
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardiac device<br>All patients implanted with a cardiac device, pacemaker(PM)or Implantable Cardioverter Defibrillator (ICD) | Procedure: In-hospital follow-up of cardiac device<br>* Electrical measures taken during normal follow-up and clinical status of the patient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac devices, In-Hospital Follow-up, Analytical