Evaluation of the " Tele-follow-up " for the Follow-up of Implantable Defibrillators
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Defibrillators, Implantable
- Sponsor
- Rennes University Hospital
- Enrollment
- 1501
- Locations
- 30
- Primary Endpoint
- Rate of major cardiovascular events: all cause death, hospitalisation for a cardiovascular event, unsuccessful ICD therapies, and inappropriate ICD therapies.
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
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.
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
Rate of major cardiovascular events: all cause death, hospitalisation for a cardiovascular event, unsuccessful ICD therapies, and inappropriate ICD therapies.
Time Frame: 1 year
Secondary Outcomes
- Time to onset of the first major cardiovascular event (censored criterion)(1 year)
- Death rate(1 year)
- Number of non programmed additional consultations at the implantation centre(1 year)
- Hospitalisation rate for a cardiovascular event(1 year)
- Cost-benefit analysis(1 year)
- Rate of unsuccessful or inappropriate ICD therapies(1 year)
- Mean costs of each follow-up strategy(1 year)
- Feasibility of the tele-follow-up in implantation centres(1 year)
- Number and cause of device re-programming(1 year)
- Number of drop-outs in the tele-follow-up group(1 year)
- Adherence of the patients to the tele-follow-up strategy(1 year)