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| ID | Type | Description | Link |
|---|---|---|---|
| 0203/076 | Other Identifier | Internal (CIC) | |
| 2007-A00888-45 | Other Identifier | IDRCB | |
| LOC/07-04 | Other Identifier | Former internal Identifier |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Tele- follow-up: remote transmission to the implantation centre every 3 months |
|
| 2 | Active Comparator | Conventional follow-up: visits at the implantation centre every 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tele- follow-up | Other | Remote transmission to the implantation centre every 3 months |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe MABO, MD, PhD | Rennes University Hospital | Study Director |
| Eric BELLISSANT, MD, PhD | Rennes University Hospital | Study Chair |
| Isabelle DURAND-ZALESKI, MD, PhD | Creteil University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Cardiologie - Centre Hospitalier du Pays d'Aix | Aix-en-Provence | 13100 | France | |||
| Service de Cardiologie - CHU d'Angers |
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| Conventional follow-up |
| Other |
Visits at the implantation centre every 3 months |
|
| 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 |
| Angers |
| 49033 |
| France |
| Service de Cardiologie - CHU Jean Minjoz | Besançon | 25000 | France |
| Service de Cardiologie -Hôpital de la Cavale Blanche | Brest | 29609 | France |
| Service de Cardiologie - Groupement Hospitalier Est de Lyon | Bron | 69677 | France |
| Service de Cardiologie - Hôpital de la Côte de Nacre | Caen | 14000 | France |
| Service de Cardiologie - CHU de Clermont-Ferrand | Clermont-Ferrand | 63000 | France |
| Service de Cardiologie - Hôpital Henri Mondor | Créteil | France |
| Centre de Cardiologie - CHU de Dijon | Dijon | 21000 | France |
| Service de cardiologie et Urgences cardiologiques - Hôpital Michallon | Grenoble | 38043 | France |
| Cardiologie A - CHRU de Lille | Lille | 59037 | France |
| Service de Cardiologie - CHU de Limoges | Limoges | 87042 | France |
| Service de Cardiologie - CHU Timone Adultes | Marseille | 13385 | France |
| Département de Cardiologie - CHU de Montpellier | Montpellier | 34295 | France |
| Service de Cardiologie - Institut du Thorax - Hôpital Laennec | Nantes | 44093 | France |
| Service de Cardiologie - Hôpital Pasteur | Nice | 06002 | France |
| Service de Cardiologie - CHU de Nîmes | Nîmes | 30029 | France |
| Service de Cardiologie - Hôpital Européen Georges Pompidou | Paris | 75015 | France |
| Service de Cardiologie - Hôpital Lariboisière | Paris | 75475 | France |
| Institut de Cardiologie - Hôpital de la Pitité Salpétrière | Paris | 75651 | France |
| Hôpital Cardiologique du Haut Lévêque - CHU de Bordeaux | Pessac | 33604 | France |
| Service médico-chirurgical de Cardiologie - CHU de Poitiers | Poitiers | 86021 | France |
| Département de Cardiologie - CHU de Reims | Reims | 51092 | France |
| Département de Cardiologie et Maladies Vasculaires - Hôpital de Pontchaillou | Rennes | 35033 | France |
| Service de Cardiologie - Hôpital Charles Nicolle | Rouen | 76031 | France |
| Service de Cardiologie - CHU de Saint Etienne | Saint-Etienne | 42000 | France |
| Service de Cardiologie - Hôpital de Hautepierre | Strasbourg | 67098 | France |
| Service de Chirurgie Cardiovasculaire - Hôpital Rangueil | Toulouse | 31059 | France |
| Service de Cardiologie B - Hôpital Trousseau | Tours | 37044 | France |
| Département de Cardiologie - CHU de Nancy-Brabois | Vandœuvre-lès-Nancy | 54511 | France |