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

Telemedicine Clinical Trial

— EVATEL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00598026
• Other study ID #: 35RC07_9901
• Secondary ID: 0203/0762007-A00
• Status: Completed
• Phase: N/A
• Start date: January 14, 2008
• Est. completion date: March 7, 2011

Study information

• Verified date: May 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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.

Related Conditions & MeSH terms

• Defibrillators, Implantable
• Telemedicine

Intervention

Other:
• Tele- follow-up
Remote transmission to the implantation centre every 3 months
• Conventional follow-up
Visits at the implantation centre every 3 months

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Rennes University Hospital	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

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