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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014