Evaluation of the " Tele-Follow-up " for the Follow-up of Implantable Defibrillators - Full Text View

Sponsors and Collaborators:	Rennes University Hospital Ministry of Health, France
Information provided by:	Rennes University Hospital
ClinicalTrials.gov Identifier:	NCT00598026

Purpose

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.

Condition	Intervention
Defibrillators, Implantable Telemedicine	Other: Tele- follow-up Other: Conventional follow-up

MedlinePlus related topics: Pacemakers and Implantable Defibrillators

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluation of the " Tele-Follow-up " for the Follow-up of Implantable Defibrillators

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:

Rate of major cardiovascular events: all cause death, hospitalisation for a cardiovascular event, unsuccessful ICD therapies, and inappropriate ICD therapies. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Time to onset of the first major cardiovascular event (censored criterion) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Death rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Hospitalisation rate for a cardiovascular event [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Rate of unsuccessful or inappropriate ICD therapies [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Mean costs of each follow-up strategy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Number of non programmed additional consultations at the implantation centre [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Number and cause of device re-programming [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Number of drop-outs in the tele-follow-up group [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Adherence of the patients to the tele-follow-up strategy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Feasibility of the tele-follow-up in implantation centres [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Cost-benefit analysis [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	1600
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Tele- follow-up: remote transmission to the implantation centre every 3 months	Other: 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	Other: Conventional follow-up Visits at the implantation centre every 3 months

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598026

Contacts

Contact: Philippe MABO, MD, PhD

33-2-9928-2510

philippe.mabo@chu-rennes.fr

Locations

France
Département de Cardiologie et Maladies Vasculaires - Hôpital de Pontchaillou	Recruiting
Rennes, France, 35033
Principal Investigator: Philippe MABO, MD, PhD
Service de Cardiologie - Centre Hospitalier du Pays d'Aix	Recruiting
Aix en Provence, France, 13100
Principal Investigator: Claude BARNAY, MD
Service de Cardiologie - CHU d'Angers	Recruiting
Angers, France, 49033
Principal Investigator: Jean-Marc DUPUIS, MD
Service de Cardiologie - CHU Jean Minjoz	Recruiting
Besancon, France, 25000
Principal Investigator: Florent BRIAND, MD
Hôpital Cardiologique du Haut Lévêque - CHU de Bordeaux	Recruiting
Pessac, France, 33604
Principal Investigator: Jacques CLEMENTY, MD, PhD
Service de Cardiologie -Hôpital de la Cavale Blanche	Recruiting
Brest, France, 29609
Principal Investigator: Jean-Jacques BLANC, MD, PhD
Service de Cardiologie - Hôpital de la Côte de Nacre	Recruiting
Caen, France, 14000
Principal Investigator: Patrice SCANU, MD
Service de Cardiologie - CHU de Clermont-Ferrand	Recruiting
Clermont-Ferrand, France, 63000
Principal Investigator: Hassan MANSOUR, MD
Centre de Cardiologie - CHU de Dijon	Recruiting
Dijon, France, 21000
Principal Investigator: Gabriel LAURENT, MD
Service de cardiologie et Urgences cardiologiques - Hôpital Michallon	Recruiting
Grenoble, France, 38043
Principal Investigator: Pascal DEFAYE, MD
Cardiologie A - CHRU de Lille	Recruiting
Lille, France, 59037
Principal Investigator: Laurence GUEDON-MOREAU, MD
Service de Cardiologie - CHU de Limoges	Recruiting
Limoges, France, 87042
Principal Investigator: Patrick BLANC, MD
Service de Cardiologie - Groupement Hospitalier Est de Lyon	Recruiting
Bron, France, 69677
Principal Investigator: Philippe CHEVALIER, MD, PhD
Service de Cardiologie - CHU Timone Adultes	Recruiting
Marseille, France, 13385
Principal Investigator: Jean-Claude DEHARO, MD, PhD
Département de Cardiologie - CHU de Montpellier	Recruiting
Montpellier, France, 34295
Principal Investigator: Jean-Marc DAVY, MD, PhD
Service de Cardiologie B - Hôpital Trousseau	Recruiting
Tours, France, 37044
Principal Investigator: Pierre COSNAY, MD, PhD
Service de Cardiologie - Institut du Thorax - Hôpital Laennec	Recruiting
Nantes, France, 44093
Principal Investigator: Hervé Le Marec, MD, PhD
Service de Cardiologie - Hôpital Pasteur	Recruiting
Nice, France, 06002
Principal Investigator: Jean-Pierre CAMOUS, MD, PhD
Service de Cardiologie - CHU de Nîmes	Recruiting
Nîmes, France, 30029
Principal Investigator: Patrick MESSNER, MD, PhD
Service de Cardiologie - Hôpital Henri Mondor	Recruiting
Créteil, France
Principal Investigator: Nathalie ELBAZ, MD
Service de Cardiologie - Hôpital Européen Georges Pompidou	Recruiting
Paris, France, 75015
Principal Investigator: Jean-Yves LE HEUZEY, MD, PhD
Service de Cardiologie - Hôpital Lariboisière	Recruiting
Paris, France, 75475
Principal Investigator: Antoine LEENHARDT, MD, PhD
Institut de Cardiologie - Hôpital de la Pitité Salpétrière	Recruiting
Paris, France, 75651
Principal Investigator: Franck ROBERT, MD
Service médico-chirurgical de Cardiologie - CHU de Poitiers	Recruiting
Poitiers, France, 86021
Principal Investigator: Alain AMIEL, MD
Département de Cardiologie - CHU de Reims	Recruiting
Reims, France, 51092
Principal Investigator: Damien METZ, MD, PhD
Service de Cardiologie - Hôpital Charles Nicolle	Recruiting
Rouen, France, 76031
Principal Investigator: Frédéric ANSELME, MD, PhD
Service de Cardiologie - CHU de Saint Etienne	Recruiting
Saint Etienne, France, 42000
Principal Investigator: Antoine DA COSTA, MD, PhD
Service de Cardiologie - Hôpital de Hautepierre	Recruiting
Strasbourg, France, 67098
Principal Investigator: Michel CHAUVIN, MD, PhD
Service de Chirurgie Cardiovasculaire - Hôpital Rangueil	Recruiting
Toulouse, France, 31059
Principal Investigator: Michèle SALVADOR-MAZENQ, MD
Département de Cardiologie - CHU de Nancy-Brabois	Recruiting
Vandoeuvre les Nancy, France, 54511
Principal Investigator: Nicolas SADOUL, MD, PhD

Sponsors and Collaborators

Rennes University Hospital

Ministry of Health, France

Investigators

Study Director:	Philippe MABO, MD, PhD	Rennes University Hospital
Study Chair:	Eric BELLISSANT, MD, PhD	Rennes University Hospital
Study Chair:	Isabelle DURAND-ZALESKI, MD, PhD	Creteil University Hospital

More Information

Responsible Party:	Rennes University Hospital ( Direction of Clinical Research and Strategy )
Study ID Numbers:	DGS 2007-A00888-45, LOC/07-04, CIC 0203/076
Study First Received:	January 9, 2008
Last Updated:	July 3, 2008
ClinicalTrials.gov Identifier:	NCT00598026
Health Authority:	France: Direction Générale de la Santé

Keywords provided by Rennes University Hospital:

Tele medicine
ICD follow-up
Cost / benefit study

ClinicalTrials.gov processed this record on January 14, 2009