Clinical trial NCT00598026: Evaluation of the " Tele-follow-up " for the Follow-up of Implantable Defibrillators
Official title: Evaluation of the " Tele-follow-up " for the Follow-up of Implantable Defibrillators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Defibrillators, Implantable
Telemedicine
Keywords: Tele medicine
ICD follow-up
Cost / benefit study
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2008-01-18
Enrollment: 1501
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of major cardiovascular events: all cause death, hospitalisation for a cardiovascular event, unsuccessful ICD therapies, and inappropriate ICD therapies.
timeFrame: 1 year
Secondary outcomes:
measure: Time to onset of the first major cardiovascular event (censored criterion)
timeFrame: 1 year
measure: Death rate
timeFrame: 1 year
measure: Hospitalisation rate for a cardiovascular event
timeFrame: 1 year
measure: Rate of unsuccessful or inappropriate ICD therapies
timeFrame: 1 year
measure: Mean costs of each follow-up strategy
timeFrame: 1 year
measure: Number of non programmed additional consultations at the implantation centre
timeFrame: 1 year
measure: Number and cause of device re-programming
timeFrame: 1 year
measure: Number of drop-outs in the tele-follow-up group
timeFrame: 1 year
measure: Adherence of the patients to the tele-follow-up strategy
timeFrame: 1 year
measure: Feasibility of the tele-follow-up in implantation centres
timeFrame: 1 year
measure: Cost-benefit analysis
timeFrame: 1 year
Other outcomes:
Locations:
city: Aix en Provence
country: France
facility: Service de Cardiologie - Centre Hospitalier du Pays d'Aix
city: Angers
country: France
facility: Service de Cardiologie - CHU d'Angers
city: Besancon
country: France
facility: Service de Cardiologie - CHU Jean Minjoz
city: Brest
country: France
facility: Service de Cardiologie -Hôpital de la Cavale Blanche
city: Bron
country: France
facility: Service de Cardiologie - Groupement Hospitalier Est de Lyon
city: Caen
country: France
facility: Service de Cardiologie - Hôpital de la Côte de Nacre
city: Clermont-Ferrand
country: France
facility: Service de Cardiologie - CHU de Clermont-Ferrand
city: Créteil
country: France
facility: Service de Cardiologie - Hôpital Henri Mondor
city: Dijon
country: France
facility: Centre de Cardiologie - CHU de Dijon
city: Grenoble
country: France
facility: Service de cardiologie et Urgences cardiologiques - Hôpital Michallon
city: Lille
country: France
facility: Cardiologie A - CHRU de Lille
city: Limoges
country: France
facility: Service de Cardiologie - CHU de Limoges
city: Marseille
country: France
facility: Service de Cardiologie - CHU Timone Adultes
city: Montpellier
country: France
facility: Département de Cardiologie - CHU de Montpellier
city: Nantes
country: France
facility: Service de Cardiologie - Institut du Thorax - Hôpital Laennec
city: Nice
country: France
facility: Service de Cardiologie - Hôpital Pasteur
city: Nîmes
country: France
facility: Service de Cardiologie - CHU de Nîmes
city: Paris
country: France
facility: Service de Cardiologie - Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: Service de Cardiologie - Hôpital Lariboisière
city: Paris
country: France
facility: Institut de Cardiologie - Hôpital de la Pitité Salpétrière
city: Pessac
country: France
facility: Hôpital Cardiologique du Haut Lévêque - CHU de Bordeaux
city: Poitiers
country: France
facility: Service médico-chirurgical de Cardiologie - CHU de Poitiers
city: Reims
country: France
facility: Département de Cardiologie - CHU de Reims
city: Rennes
country: France
facility: Département de Cardiologie et Maladies Vasculaires - Hôpital de Pontchaillou
city: Rouen
country: France
facility: Service de Cardiologie - Hôpital Charles Nicolle
city: Saint Etienne
country: France
facility: Service de Cardiologie - CHU de Saint Etienne
city: Strasbourg
country: France
facility: Service de Cardiologie - Hôpital de Hautepierre
city: Toulouse
country: France
facility: Service de Chirurgie Cardiovasculaire - Hôpital Rangueil
city: Tours
country: France
facility: Service de Cardiologie B - Hôpital Trousseau
city: Vandoeuvre les Nancy
country: France
facility: Département de Cardiologie - CHU de Nancy-Brabois
Study officials:
affiliation: Rennes University Hospital
name: Philippe MABO, MD, PhD
role: STUDY_DIRECTOR
affiliation: Rennes University Hospital
name: Eric BELLISSANT, MD, PhD
role: STUDY_CHAIR
affiliation: Creteil University Hospital
name: Isabelle DURAND-ZALESKI, MD, PhD
role: STUDY_CHAIR
References: