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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01073449
Recruitment Status : Completed
First Posted : February 23, 2010
Results First Posted : February 28, 2011
Last Update Posted : February 28, 2011
Information provided by:
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.

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

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 Type : Observational
Actual Enrollment : 3362 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Action Elicited By Scheduled In-Hospital Follow-Up of Cardiac Devices
Study Start Date : February 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients who will undergo an in-hospital follow-up of a cardiac device

Inclusion Criteria:

  • All patients with a cardiac device

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01073449

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
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