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

NCT00598026 | Completed DMC

• 4 other identifiers: 35RC07_99010203/0762007-A00888-45LOC/07-04
• Study Type: interventional
• Target: 1,501
• Locations: 1 country
• Sites: 30

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.

Conditions

Defibrillators, Implantable; Telemedicine

Keywords

Tele medicine; ICD follow-up; Cost / benefit study

Outcome Measures

Primary Outcomes (1)

• Rate of major cardiovascular events: all cause death, hospitalisation for a cardiovascular event, unsuccessful ICD therapies, and inappropriate ICD therapies.

  1 year

Secondary Outcomes (11)

• Time to onset of the first major cardiovascular event (censored criterion)

  1 year

• Death rate

  1 year

• Hospitalisation rate for a cardiovascular event

  1 year

• Rate of unsuccessful or inappropriate ICD therapies

  1 year

• Mean costs of each follow-up strategy

  1 year

Study Arms (2)

1

EXPERIMENTAL

Tele- follow-up: remote transmission to the implantation centre every 3 months

Other: Tele- follow-up

2

ACTIVE COMPARATOR

Conventional follow-up: visits at the implantation centre every 3 months

Other: Conventional follow-up

Interventions

Tele- follow-up OTHER

Remote transmission to the implantation centre every 3 months

1

Conventional follow-up OTHER

Visits at the implantation centre every 3 months

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Class IV of NYHA,
• Concomitant pathology leading to a life expectancy inferior to the protocol duration,
• Concomitant participation to another protocol.

Sponsors & Collaborators

• Rennes University Hospital: lead
• Ministry of Health, France: collaborator

Study Sites (30)

Service de Cardiologie - Centre Hospitalier du Pays d'Aix

Aix-en-Provence, 13100, France

Location

Service de Cardiologie - CHU d'Angers

Angers, 49033, France

Location

Service de Cardiologie - CHU Jean Minjoz

Besançon, 25000, France

Location

Service de Cardiologie -Hôpital de la Cavale Blanche

Brest, 29609, France

Location

Service de Cardiologie - Groupement Hospitalier Est de Lyon

Bron, 69677, France

Location

Service de Cardiologie - Hôpital de la Côte de Nacre

Caen, 14000, France

Location

Service de Cardiologie - CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

Service de Cardiologie - Hôpital Henri Mondor

Créteil, France

Location

Centre de Cardiologie - CHU de Dijon

Dijon, 21000, France

Location

Service de cardiologie et Urgences cardiologiques - Hôpital Michallon

Grenoble, 38043, France

Location

Cardiologie A - CHRU de Lille

Lille, 59037, France

Location

Service de Cardiologie - CHU de Limoges

Limoges, 87042, France

Location

Service de Cardiologie - CHU Timone Adultes

Marseille, 13385, France

Location

Département de Cardiologie - CHU de Montpellier

Montpellier, 34295, France

Location

Service de Cardiologie - Institut du Thorax - Hôpital Laennec

Nantes, 44093, France

Location

Service de Cardiologie - Hôpital Pasteur

Nice, 06002, France

Location

Service de Cardiologie - CHU de Nîmes

Nîmes, 30029, France

Location

Service de Cardiologie - Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Service de Cardiologie - Hôpital Lariboisière

Paris, 75475, France

Location

Institut de Cardiologie - Hôpital de la Pitité Salpétrière

Paris, 75651, France

Location

Hôpital Cardiologique du Haut Lévêque - CHU de Bordeaux

Pessac, 33604, France

Location

Service médico-chirurgical de Cardiologie - CHU de Poitiers

Poitiers, 86021, France

Location

Département de Cardiologie - CHU de Reims

Reims, 51092, France

Location

Département de Cardiologie et Maladies Vasculaires - Hôpital de Pontchaillou

Rennes, 35033, France

Location

Service de Cardiologie - Hôpital Charles Nicolle

Rouen, 76031, France

Location

Service de Cardiologie - CHU de Saint Etienne

Saint-Etienne, 42000, France

Location

Service de Cardiologie - Hôpital de Hautepierre

Strasbourg, 67098, France

Location

Service de Chirurgie Cardiovasculaire - Hôpital Rangueil

Toulouse, 31059, France

Location

Service de Cardiologie B - Hôpital Trousseau

Tours, 37044, France

Location

Département de Cardiologie - CHU de Nancy-Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Study Officials

• Philippe MABO, MD, PhD

  Rennes University Hospital

  STUDY DIRECTOR

• Eric BELLISSANT, MD, PhD

  Rennes University Hospital

  STUDY CHAIR

• Isabelle DURAND-ZALESKI, MD, PhD

  Creteil University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2008
• First Posted: January 18, 2008
• Study Start: January 14, 2008
• Primary Completion: March 7, 2011
• Study Completion: March 7, 2011
• Last Updated: May 11, 2023

Record last verified: 2023-05

Locations

FR (30)