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NCT00598026 Clinical Trial

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

Telemedicine Clinical Trial

— EVATEL  

Official title:
Evaluation of the " Tele-follow-up " for the Follow-up of Implantable Defibrillators

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00598026
Other study ID # 35RC07_9901
Secondary ID 0203/0762007-A00
Status Completed
Phase N/A
First received
Last updated
Start date January 14, 2008
Est. completion date March 7, 2011

Study information
Verified date May 2023
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

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Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Tele- follow-up
Remote transmission to the implantation centre every 3 months
• Conventional follow-up
Visits at the implantation centre every 3 months
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Sponsors (2)
Lead Sponsor Collaborator
Rennes University Hospital Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of major cardiovascular events: all cause death, hospitalisation for a cardiovascular event, unsuccessful ICD therapies, and inappropriate ICD therapies. 1 year
Secondary Time to onset of the first major cardiovascular event (censored criterion) 1 year
Secondary Death rate 1 year
Secondary Hospitalisation rate for a cardiovascular event 1 year
Secondary Rate of unsuccessful or inappropriate ICD therapies 1 year
Secondary Mean costs of each follow-up strategy 1 year
Secondary Number of non programmed additional consultations at the implantation centre 1 year
Secondary Number and cause of device re-programming 1 year
Secondary Number of drop-outs in the tele-follow-up group 1 year
Secondary Adherence of the patients to the tele-follow-up strategy 1 year
Secondary Feasibility of the tele-follow-up in implantation centres 1 year
Secondary Cost-benefit analysis 1 year
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