Evaluation of the " Tele-follow-up " for the Follow-up of Implantable Defibrillators
- Conditions
- Defibrillators, ImplantableTelemedicine
- Interventions
- Other: Tele- follow-upOther: Conventional follow-up
- Registration Number
- NCT00598026
- Lead Sponsor
- Rennes University Hospital
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1501
- 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.
- Class IV of NYHA,
- Concomitant pathology leading to a life expectancy inferior to the protocol duration,
- Concomitant participation to another protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Tele- follow-up Tele- follow-up: remote transmission to the implantation centre every 3 months 2 Conventional follow-up Conventional follow-up: visits at the implantation centre every 3 months
- Primary Outcome Measures
Name Time Method 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
Name Time Method Death rate 1 year Number and cause of device re-programming 1 year Time to onset of the first major cardiovascular event (censored criterion) 1 year Number of non programmed additional consultations at the implantation centre 1 year Hospitalisation rate for a cardiovascular event 1 year Cost-benefit analysis 1 year Rate of unsuccessful or inappropriate ICD therapies 1 year Mean costs of each follow-up strategy 1 year Feasibility of the tele-follow-up in implantation centres 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
Trial Locations
- Locations (30)
Cardiologie A - CHRU de Lille
馃嚝馃嚪Lille, France
Service de cardiologie et Urgences cardiologiques - H么pital Michallon
馃嚝馃嚪Grenoble, France
Service de Cardiologie - Groupement Hospitalier Est de Lyon
馃嚝馃嚪Bron, France
Service de Cardiologie -H么pital de la Cavale Blanche
馃嚝馃嚪Brest, France
Service de Cardiologie - H么pital de la C么te de Nacre
馃嚝馃嚪Caen, France
Service de Cardiologie - CHU d'Angers
馃嚝馃嚪Angers, France
Centre de Cardiologie - CHU de Dijon
馃嚝馃嚪Dijon, France
Service de Cardiologie - CHU Jean Minjoz
馃嚝馃嚪Besancon, France
Service de Cardiologie - Institut du Thorax - H么pital Laennec
馃嚝馃嚪Nantes, France
Service de Cardiologie - Centre Hospitalier du Pays d'Aix
馃嚝馃嚪Aix en Provence, France
Service de Cardiologie - H么pital Henri Mondor
馃嚝馃嚪Cr茅teil, France
Service de Cardiologie - CHU de Clermont-Ferrand
馃嚝馃嚪Clermont-Ferrand, France
Service de Cardiologie - CHU de Limoges
馃嚝馃嚪Limoges, France
Service de Cardiologie - H么pital Pasteur
馃嚝馃嚪Nice, France
Service de Cardiologie - CHU de N卯mes
馃嚝馃嚪N卯mes, France
D茅partement de Cardiologie - CHU de Montpellier
馃嚝馃嚪Montpellier, France
Service de Cardiologie - H么pital Europ茅en Georges Pompidou
馃嚝馃嚪Paris, France
Service de Cardiologie - H么pital Lariboisi猫re
馃嚝馃嚪Paris, France
Institut de Cardiologie - H么pital de la Pitit茅 Salp茅tri猫re
馃嚝馃嚪Paris, France
H么pital Cardiologique du Haut L茅v锚que - CHU de Bordeaux
馃嚝馃嚪Pessac, France
D茅partement de Cardiologie - CHU de Reims
馃嚝馃嚪Reims, France
Service m茅dico-chirurgical de Cardiologie - CHU de Poitiers
馃嚝馃嚪Poitiers, France
Service de Cardiologie - H么pital de Hautepierre
馃嚝馃嚪Strasbourg, France
D茅partement de Cardiologie et Maladies Vasculaires - H么pital de Pontchaillou
馃嚝馃嚪Rennes, France
Service de Cardiologie - H么pital Charles Nicolle
馃嚝馃嚪Rouen, France
Service de Cardiologie - CHU de Saint Etienne
馃嚝馃嚪Saint Etienne, France
Service de Cardiologie B - H么pital Trousseau
馃嚝馃嚪Tours, France
D茅partement de Cardiologie - CHU de Nancy-Brabois
馃嚝馃嚪Vandoeuvre les Nancy, France
Service de Chirurgie Cardiovasculaire - H么pital Rangueil
馃嚝馃嚪Toulouse, France
Service de Cardiologie - CHU Timone Adultes
馃嚝馃嚪Marseille, France