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Evaluation of the " Tele-follow-up " for the Follow-up of Implantable Defibrillators (EVATEL)

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00598026
First received: January 9, 2008
Last updated: February 23, 2012
Last verified: February 2012

January 9, 2008
February 23, 2012
January 2008
January 2011   (final data collection date for primary outcome measure)
Rate of major cardiovascular events: all cause death, hospitalisation for a cardiovascular event, unsuccessful ICD therapies, and inappropriate ICD therapies. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00598026 on ClinicalTrials.gov Archive Site
  • Time to onset of the first major cardiovascular event (censored criterion) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Death rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Hospitalisation rate for a cardiovascular event [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Rate of unsuccessful or inappropriate ICD therapies [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Mean costs of each follow-up strategy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Number of non programmed additional consultations at the implantation centre [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Number and cause of device re-programming [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Number of drop-outs in the tele-follow-up group [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Adherence of the patients to the tele-follow-up strategy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Feasibility of the tele-follow-up in implantation centres [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Cost-benefit analysis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evaluation of the " Tele-follow-up " for the Follow-up of Implantable Defibrillators
Evaluation of the " Tele-follow-up " for the Follow-up of Implantable Defibrillators

The implantable cardioverter defibrillator (ICD) has been shown to be effective in preventing mortality in patients with ventricular tachyarrhythmia. However, the expanding indications of this therapy will have an impact on the follow-up policy. Currently, regular follow-up visits are scheduled every 3 months. In this context, the recently-introduced "remote monitoring" devices constitute a promising new technique, allowing to transmit information about the status of the device and ICD therapies, without direct contact between patients and physicians. This monitoring by "tele-follow-up" might reduce the cost of care by avoiding useless visits to the implantation centre.

The aim of our study is to assess the cost-benefit ratio of "tele-follow-up" assisted care as compared with the conventional ICD follow-up.

The implantable cardioverter defibrillator (ICD) has been shown to be effective in preventing mortality in patients with ventricular tachyarrhythmia. However, the expanding indications of this therapy will have an impact on the follow-up policy. Currently, regular follow-up visits are scheduled every 3 months. In this context, the recently-introduced "remote monitoring" devices constitute a promising new technique, allowing to transmit information about the status of the device and ICD therapies, without direct contact between patients and physicians. This monitoring by "tele-follow-up" might reduce the cost of care by avoiding useless visits to the implantation centre.

The aim of our study is to assess the cost-benefit ratio of "tele-follow-up" assisted care as compared with the conventional ICD follow-up. Thanks to an open label, randomized, 2 arms study : one using a telephone follow up, the other a conventional follow-up.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • Defibrillators, Implantable
  • Telemedicine
  • Other: Tele- follow-up
    Remote transmission to the implantation centre every 3 months
  • Other: Conventional follow-up
    Visits at the implantation centre every 3 months
  • Experimental: 1
    Tele- follow-up: remote transmission to the implantation centre every 3 months
    Intervention: Other: Tele- follow-up
  • Active Comparator: 2
    Conventional follow-up: visits at the implantation centre every 3 months
    Intervention: Other: Conventional follow-up
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1501
May 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults over 18,
  • First implantation of an implantable cardioverter defibrillator device (CRT-D devices being excluded), single or dual-chamber in primary or secondary prevention,
  • ICD with data-transmission features,
  • GSM mobile phone network at patient home compatible with remote transmission,
  • Patient able to use correctly the transmission system,
  • Patients having given a written informed consent.

Exclusion Criteria:

  • Class IV of NYHA,
  • Concomitant pathology leading to a life expectancy inferior to the protocol duration,
  • Concomitant participation to another protocol.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00598026
DGS 2007-A00888-45, LOC/07-04, CIC 0203/076
Yes
Rennes University Hospital
Rennes University Hospital
Ministry of Health, France
Study Director: Philippe MABO, MD, PhD Rennes University Hospital
Study Chair: Eric BELLISSANT, MD, PhD Rennes University Hospital
Study Chair: Isabelle DURAND-ZALESKI, MD, PhD Creteil University Hospital
Rennes University Hospital
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP