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

Not Applicable

Completed

• Conditions: Defibrillators, Implantable; Telemedicine

• 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.

Study Timeline

• Study First Submitted: 2008-01-09
• Study Start: 2008-01-14
• Study First Submitted QC: 2008-01-17
• Study First Posted: 2008-01-18
• Primary Completion: 2011-03-07
• Study Completion: 2011-03-07
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1501

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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
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
Mean costs of each follow-up strategy	1 year
Feasibility of the tele-follow-up in implantation centres	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
Death rate	1 year
Rate of unsuccessful or inappropriate ICD therapies	1 year

Trial Locations

Locations (30)

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

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