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

NCT00598026 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1501

Last updated 2023-05-11

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Rennes University Hospital

    lead OTHER

Principal Investigators

  • Philippe MABO, MD, PhD · Rennes University Hospital

  • Eric BELLISSANT, MD, PhD · Rennes University Hospital

  • Isabelle DURAND-ZALESKI, MD, PhD · Creteil University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-14
Primary Completion
2011-03-07
Completion
2011-03-07

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00598026 on ClinicalTrials.gov