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

Rennes University Hospital

Status: Completed

Conditions: Defibrillators, Implantable; Telemedicine

Treatments: Other: Tele- follow-up; Other: Conventional follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT00598026

2007-A00888-45 (Other Identifier)

0203/076 (Other Identifier)

35RC07_9901

LOC/07-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,501 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,501 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Other: Tele- follow-up

2

Active Comparator group

Description:

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

Treatment:

Other: Conventional follow-up