Actions Elicited by 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.

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Key information

Conditions

Cardiac Pacemaker, Artificial Implantable Cardioverter-defibrillator

Sex eligibility

All sexes

Study type

Observational

Primary location

U.O. Aritmologia - Cliniche Humanitas Gavazzeni, Bergamo, Italy

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients with a cardiac device

Exclusion criteria

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

Treatment and study plan

In-hospital follow-up of cardiac device

Procedure

Electrical measures taken during normal follow-up and clinical status of the patient

Primary outcomes

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

Time frame: 4 months

Secondary outcomes

Number of Patients -Amongst Those Implanted With a Pacemaker - in Whom Something (Therapy, Device Programming ...) Has Been Changed During In-hospital Follow-up

Time frame: 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

Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Cliniche Humanitas Gavazzeni

Other

Registry information

Official study title

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

Acronym: ATHENS

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Feb 23, 2010
Registry last updated: Feb 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed