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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00598026
First received: January 9, 2008
Last updated: February 23, 2012
Last verified: February 2012
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Evaluation of the " Tele-follow-up " for the Follow-up of Implantable Defibrillators

Resource links provided by NLM:


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 ]

Enrollment: 1501
Study Start Date: January 2008
Study Completion Date: May 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Active Comparator: 2
Conventional follow-up: visits at the implantation centre every 3 months
Other: Conventional follow-up
Visits at the implantation centre every 3 months

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Service de Cardiologie - Centre Hospitalier du Pays d'Aix
Aix en Provence, France, 13100
Service de Cardiologie - CHU d'Angers
Angers, France, 49033
Service de Cardiologie - CHU Jean Minjoz
Besancon, France, 25000
Service de Cardiologie -Hôpital de la Cavale Blanche
Brest, France, 29609
Service de Cardiologie - Groupement Hospitalier Est de Lyon
Bron, France, 69677
Service de Cardiologie - Hôpital de la Côte de Nacre
Caen, France, 14000
Service de Cardiologie - CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63000
Service de Cardiologie - Hôpital Henri Mondor
Créteil, France
Centre de Cardiologie - CHU de Dijon
Dijon, France, 21000
Service de cardiologie et Urgences cardiologiques - Hôpital Michallon
Grenoble, France, 38043
Cardiologie A - CHRU de Lille
Lille, France, 59037
Service de Cardiologie - CHU de Limoges
Limoges, France, 87042
Service de Cardiologie - CHU Timone Adultes
Marseille, France, 13385
Département de Cardiologie - CHU de Montpellier
Montpellier, France, 34295
Service de Cardiologie - Institut du Thorax - Hôpital Laennec
Nantes, France, 44093
Service de Cardiologie - Hôpital Pasteur
Nice, France, 06002
Service de Cardiologie - CHU de Nîmes
Nîmes, France, 30029
Service de Cardiologie - Hôpital Lariboisière
Paris, France, 75475
Institut de Cardiologie - Hôpital de la Pitité Salpétrière
Paris, France, 75651
Service de Cardiologie - Hôpital Européen Georges Pompidou
Paris, France, 75015
Hôpital Cardiologique du Haut Lévêque - CHU de Bordeaux
Pessac, France, 33604
Service médico-chirurgical de Cardiologie - CHU de Poitiers
Poitiers, France, 86021
Département de Cardiologie - CHU de Reims
Reims, France, 51092
Département de Cardiologie et Maladies Vasculaires - Hôpital de Pontchaillou
Rennes, France, 35033
Service de Cardiologie - Hôpital Charles Nicolle
Rouen, France, 76031
Service de Cardiologie - CHU de Saint Etienne
Saint Etienne, France, 42000
Service de Cardiologie - Hôpital de Hautepierre
Strasbourg, France, 67098
Service de Chirurgie Cardiovasculaire - Hôpital Rangueil
Toulouse, France, 31059
Service de Cardiologie B - Hôpital Trousseau
Tours, France, 37044
Département de Cardiologie - CHU de Nancy-Brabois
Vandoeuvre les Nancy, France, 54511
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

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT00598026     History of Changes
Other Study ID Numbers: DGS 2007-A00888-45, LOC/07-04, CIC 0203/076
Study First Received: January 9, 2008
Last Updated: February 23, 2012
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 October 22, 2014