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

Completed

• Conditions: Cardiac Pacemaker, Artificial; Implantable Cardioverter-Defibrillator
• Interventions: Procedure: In-hospital follow-up of cardiac device

• Registration Number: NCT01073449
• Lead Sponsor: Cliniche Humanitas Gavazzeni

Brief 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.

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 Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-22
• Study First Submitted QC: 2010-02-22
• Study First Posted: 2010-02-23
• Status Verified: 2011-01
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Results First Submitted: 2011-01-10
• Results First Submitted QC: 2011-02-02
• Last Update Submitted: 2011-02-02
• Results First Posted: 2011-02-28
• Last Update Posted: 2011-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3362

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cardiac device	In-hospital follow-up of cardiac device	All patients implanted with a cardiac device, pacemaker(PM)or Implantable Cardioverter Defibrillator (ICD)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (7)

Laboratorio di Elettrofisiologia; 🇮🇹 Merate, Lecco, Italy

Laboratorio di Cardiologia - Ospedale Civile; 🇮🇹 Casalmaggiore, Cremona, Italy

U.O. Aritmologia - Cliniche Humanitas Gavazzeni; 🇮🇹 Bergamo, Italy

Laboratorio di Elettrofisiologia - Ospedale Carlo Poma; 🇮🇹 Mantova, Italy

Laboratorio di Elettrofisiologia - Spedali Civili; 🇮🇹 Brescia, Italy

Laboratorio di Elettrofisiologia - Ospedale A. Manzoni; 🇮🇹 Lecco, Italy

Laboratorio di Elettrofisiologia - Ospedale San Matteo; 🇮🇹 Pavia, Italy