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Completed

NCT Number: NCT00598026

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Cardiologie - Centre Hospitalier du Pays d'Aix, Aix-en-Provence, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tele- follow-up

Other

Remote transmission to the implantation centre every 3 months

Conventional follow-up

Other

Visits at the implantation centre every 3 months

Primary outcomes

  1. Rate of major cardiovascular events: all cause death, hospitalisation for a cardiovascular event, unsuccessful ICD therapies, and inappropriate ICD therapies.

    Time frame: 1 year

Secondary outcomes

  1. Time to onset of the first major cardiovascular event (censored criterion)

    Time frame: 1 year

  2. Death rate

    Time frame: 1 year

  3. Hospitalisation rate for a cardiovascular event

    Time frame: 1 year

  4. Rate of unsuccessful or inappropriate ICD therapies

    Time frame: 1 year

  5. Mean costs of each follow-up strategy

    Time frame: 1 year

  6. Number of non programmed additional consultations at the implantation centre

    Time frame: 1 year

  7. Number and cause of device re-programming

    Time frame: 1 year

  8. Number of drop-outs in the tele-follow-up group

    Time frame: 1 year

  9. Adherence of the patients to the tele-follow-up strategy

    Time frame: 1 year

  10. Feasibility of the tele-follow-up in implantation centres

    Time frame: 1 year

  11. Cost-benefit analysis

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Collaborators

  • Ministry of Health, France

Registry information

Acronym: EVATEL

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jan 18, 2008
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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