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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of the  Tele-follow-up  for the Follow-up of Implantable Defibrillators

Conditions
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Defibrillators, Implantable, Telemedicine

Intervention / Treatment
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* Other: Tele- follow-up
* Other: Conventional follow-up


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Tele- follow-up: remote transmission to the implantation centre every 3 months | Other: Tele- follow-up<br>* Remote transmission to the implantation centre every 3 months<br>|
| Active Comparator: 2<br>Conventional follow-up: visits at the implantation centre every 3 months | Other: Conventional follow-up<br>* Visits at the implantation centre every 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of major cardiovascular events: all cause death, hospitalisation for a cardiovascular event, unsuccessful ICD therapies, and inappropriate ICD therapies. |  | 1 year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tele medicine, ICD follow-up, Cost / benefit study