NCT00598026

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,501 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Defibrillators, Implantable
• Telemedicine

Interventions

Type	Name	Description
OTHER	Tele- follow-up	Remote transmission to the implantation centre every 3 months
OTHER	Conventional follow-up	Visits at the implantation centre every 3 months

Timeline

• Start date: 2008-01-14
• Primary completion: 2011-03-07
• Completion: 2011-03-07
• First posted: 2008-01-18
• Last updated: 2023-05-11

Locations

30 sites across 1 country: France