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European Health Economic Trial on Home Monitoring in ICD and CRT-D Patients (EuroEco)

NCT00776087 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 409

Last updated 2017-07-02

No results posted yet for this study

Summary

BIOTRONIK Home Monitoring (HM) service enables the doctors to safely follow up (FU) their ICD and CRT-D patients in a remote fashion, with fewer in-clinic consultations. This may result in a more efficient FU and cost-savings for the health care payer.

The EuroEco study:

1. Outlines a new HM-based FU model for the ICD and CRT-D patients that combines in-clinic consultations and regular check ups of the patient/ICD/CRT-D data received through the HM service.
2. Compares the direct costs for physicians and clinics for the HM-based FU of ICD and CRT-D patients versus the traditional FU.
3. Compares the indicators of patients' safety between the two FU models.

Conditions

  • Ventricular Fibrillation
  • Tachycardia, Ventricular
  • Ventricular Flutter

Interventions

DEVICE

Home Monitoring provided by Biotronik ICD and CRT-D devices

Remote monitoring of ICD and CRT-D function and patient status may result in more effective follow-up and increased patient safety

DEVICE

No Home Monitoring

Home Monitoring option is switched off (in the same kind of devices as used in the other study arm).

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    lead INDUSTRY

Principal Investigators

  • Hein Heidbüchel, Prof. Dr. · ZU Gasthuisberg, Leuven, Belgium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-17
Primary Completion
2016-07-21
Completion
2016-10-27

Countries

  • Belgium
  • Finland
  • Germany
  • Netherlands
  • Spain
  • United Kingdom

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 NCT00776087 on ClinicalTrials.gov