Evaluation of the " Tele-follow-up " for the Follow-up of Implantable Defibrillators
NCT ID: NCT00598026
Last Updated: 2023-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1501 participants
INTERVENTIONAL
2008-01-14
2011-03-07
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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1
Tele- follow-up: remote transmission to the implantation centre every 3 months
Tele- follow-up
Remote transmission to the implantation centre every 3 months
2
Conventional follow-up: visits at the implantation centre every 3 months
Conventional follow-up
Visits at the implantation centre every 3 months
Interventions
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Tele- follow-up
Remote transmission to the implantation centre every 3 months
Conventional follow-up
Visits at the implantation centre every 3 months
Eligibility Criteria
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Inclusion Criteria
* 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
* Concomitant pathology leading to a life expectancy inferior to the protocol duration,
* Concomitant participation to another protocol.
18 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
Rennes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Philippe MABO, MD, PhD
Role: STUDY_DIRECTOR
Rennes University Hospital
Eric BELLISSANT, MD, PhD
Role: STUDY_CHAIR
Rennes University Hospital
Isabelle DURAND-ZALESKI, MD, PhD
Role: STUDY_CHAIR
Creteil University Hospital
Locations
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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
Besançon, , 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
Service de Cardiologie - Hôpital Européen Georges Pompidou
Paris, , France
Service de Cardiologie - Hôpital Lariboisière
Paris, , France
Institut de Cardiologie - Hôpital de la Pitité Salpétrière
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
Vandœuvre-lès-Nancy, , France
Countries
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Other Identifiers
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0203/076
Identifier Type: OTHER
Identifier Source: secondary_id
2007-A00888-45
Identifier Type: OTHER
Identifier Source: secondary_id
LOC/07-04
Identifier Type: OTHER
Identifier Source: secondary_id
35RC07_9901
Identifier Type: -
Identifier Source: org_study_id
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