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

This study has been completed.
Sponsor:
Information provided by:
Cliniche Humanitas Gavazzeni
ClinicalTrials.gov Identifier:
NCT01073449
First received: February 22, 2010
Last updated: February 2, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention
Cardiac Pacemaker, Artificial
Implantable Cardioverter-Defibrillator
Procedure: In-hospital follow-up of cardiac device

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Action Elicited By Scheduled In-Hospital Follow-Up of Cardiac Devices

Resource links provided by NLM:


Further study details as provided by Cliniche Humanitas Gavazzeni:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 3362
Study Start Date: February 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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?
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • All patients with a cardiac device

Exclusion Criteria:

  • Follow-up of a cardiac device at discharge from hospital after first implant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01073449

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: U.O. Aritmologia - Cliniche Humanitas Gavazzeni, Dr. Giosuè Mascioli
ClinicalTrials.gov Identifier: NCT01073449     History of Changes
Other Study ID Numbers: GAVBS1
Study First Received: February 22, 2010
Results First Received: January 10, 2011
Last Updated: February 2, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Cliniche Humanitas Gavazzeni:
Cardiac devices
In-Hospital Follow-up
Analytical

ClinicalTrials.gov processed this record on April 15, 2014