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

Cliniche Humanitas Gavazzeni

Status: Completed

Conditions: Implantable Cardioverter-Defibrillator; Cardiac Pacemaker, Artificial

Treatments: Procedure: In-hospital follow-up of cardiac device

Study type: Observational

Funder types: Other

Identifiers

NCT01073449

GAVBS1

Details and patient eligibility

About

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.

Full 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?

Enrollment: 3,362 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients with a cardiac device

Exclusion criteria

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

Trial design

3,362 participants in 1 patient group

Cardiac device

Description:

All patients implanted with a cardiac device, pacemaker(PM)or Implantable Cardioverter Defibrillator (ICD)

Treatment:

Procedure: In-hospital follow-up of cardiac device