Telemedicine Clinical Trial
— EVATELOfficial title:
Evaluation of the " Tele-follow-up " for the Follow-up of Implantable Defibrillators
Verified date | May 2023 |
Source | Rennes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1501 |
Est. completion date | March 7, 2011 |
Est. primary completion date | March 7, 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | 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 | Besancon | |
France | Service de Cardiologie -Hôpital de la Cavale Blanche | Brest | |
France | Service de Cardiologie - Groupement Hospitalier Est de Lyon | Bron | |
France | Service de Cardiologie - Hôpital de la Côte de Nacre | Caen | |
France | Service de Cardiologie - CHU de Clermont-Ferrand | Clermont-Ferrand | |
France | Service de Cardiologie - Hôpital Henri Mondor | Créteil | |
France | Centre de Cardiologie - CHU de Dijon | Dijon | |
France | Service de cardiologie et Urgences cardiologiques - Hôpital Michallon | Grenoble | |
France | Cardiologie A - CHRU de Lille | Lille | |
France | Service de Cardiologie - CHU de Limoges | Limoges | |
France | Service de Cardiologie - CHU Timone Adultes | Marseille | |
France | Département de Cardiologie - CHU de Montpellier | Montpellier | |
France | Service de Cardiologie - Institut du Thorax - Hôpital Laennec | Nantes | |
France | Service de Cardiologie - Hôpital Pasteur | Nice | |
France | Service de Cardiologie - CHU de Nîmes | Nîmes | |
France | Institut de Cardiologie - Hôpital de la Pitité Salpétrière | Paris | |
France | Service de Cardiologie - Hôpital Européen Georges Pompidou | Paris | |
France | Service de Cardiologie - Hôpital Lariboisière | Paris | |
France | Hôpital Cardiologique du Haut Lévêque - CHU de Bordeaux | Pessac | |
France | Service médico-chirurgical de Cardiologie - CHU de Poitiers | Poitiers | |
France | Département de Cardiologie - CHU de Reims | Reims | |
France | Département de Cardiologie et Maladies Vasculaires - Hôpital de Pontchaillou | Rennes | |
France | Service de Cardiologie - Hôpital Charles Nicolle | Rouen | |
France | Service de Cardiologie - CHU de Saint Etienne | Saint Etienne | |
France | Service de Cardiologie - Hôpital de Hautepierre | Strasbourg | |
France | Service de Chirurgie Cardiovasculaire - Hôpital Rangueil | Toulouse | |
France | Service de Cardiologie B - Hôpital Trousseau | Tours | |
France | Département de Cardiologie - CHU de Nancy-Brabois | Vandoeuvre les Nancy |
Lead Sponsor | Collaborator |
---|---|
Rennes University Hospital | Ministry of Health, France |
France,
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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