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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
1,501
Remote transmission to the implantation centre every 3 months
Visits at the implantation centre every 3 months
Service de Cardiologie - Centre Hospitalier du Pays d'Aix
Aix-en-Provence, France
Service de Cardiologie - CHU d'Angers
Angers, France
Service de Cardiologie - CHU Jean Minjoz
Besançon, France
Service de Cardiologie -Hôpital de la Cavale Blanche
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Service de Cardiologie - Groupement Hospitalier Est de Lyon
Bron, France
Rate of major cardiovascular events: all cause death, hospitalisation for a cardiovascular event, unsuccessful ICD therapies, and inappropriate ICD therapies.
Time frame: 1 year
Time to onset of the first major cardiovascular event (censored criterion)
Time frame: 1 year
Death rate
Time frame: 1 year
Hospitalisation rate for a cardiovascular event
Time frame: 1 year
Rate of unsuccessful or inappropriate ICD therapies
Time frame: 1 year
Mean costs of each follow-up strategy
Time frame: 1 year
Number of non programmed additional consultations at the implantation centre
Time frame: 1 year
Number and cause of device re-programming
Time frame: 1 year
Number of drop-outs in the tele-follow-up group
Time frame: 1 year
Adherence of the patients to the tele-follow-up strategy
Time frame: 1 year
Feasibility of the tele-follow-up in implantation centres
Time frame: 1 year
Cost-benefit analysis
Time frame: 1 year
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