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Sponsors and Collaborators: |
Rennes University Hospital Ministry of Health, France |
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Information provided by: | Rennes University Hospital |
ClinicalTrials.gov Identifier: | NCT00598026 |
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 |
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Defibrillators, Implantable Telemedicine |
Other: Tele- follow-up Other: Conventional follow-up |
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 |
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 |
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1: Experimental
Tele- follow-up: remote transmission to the implantation centre every 3 months
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Other: Tele- follow-up
Remote transmission to the implantation centre every 3 months
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2: Active Comparator
Conventional follow-up: visits at the implantation centre every 3 months
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Other: Conventional follow-up
Visits at the implantation centre every 3 months
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Philippe MABO, MD, PhD | 33-2-9928-2510 | philippe.mabo@chu-rennes.fr |
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 |
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 |
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: | January 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00598026 History of Changes |
Health Authority: | France: Direction Générale de la Santé |
Tele medicine ICD follow-up Cost / benefit study |