- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00776087
European Health Economic Trial on Home Monitoring in ICD and CRT-D Patients (EuroEco) (EuroEco)
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:
- 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.
- Compares the direct costs for physicians and clinics for the HM-based FU of ICD and CRT-D patients versus the traditional FU.
- Compares the indicators of patients' safety between the two FU models.
Study Overview
Status
Intervention / Treatment
Detailed Description
The EuroEco is a prospective, international, randomized study aimed at assessing the economic effects of BIOTRONIK Home Monitoring (HM) technology as compared with traditional follow up (FU) of ICD and CRT-D patients from two perspectives: 1) the cost-effectiveness for the payer of health care, and 2) the economic impact on the physician, hospital and patient. The study outlines a new model for the FU of ICD-and CRT-D patients based on a combination of in-clinic consultations and regular check ups of the patient data received through the HM service.
About 312 patients with an indication for ICD therapy and 104 patients with an indication for de novo CRT-D implantation should be enrolled. All patients will be implanted with BIOTRONIK ICD or CRT-D devices from the Lumax families and randomized (1:1) to the traditional, or to HM-based FU model. Traditional FU will be performed according to the local clinical practice. Patients in the HM study arm will first undergo local clinical FU routine until the first in-clinic visit after patient discharge. Thereafter routine in-clinic FUs are scheduled at 12 and 24 months. Three HM data checks should be carried out during each 12-month interval, to assess the patient/ICD/CRT-D status remotely.
In both (HM and no HM) groups, additional in-hospital FU may be scheduled any time the patients reports symptoms which are presumed to be cardiovascular symptoms. In the HM group, additional in-clinic FU may also be scheduled as a result of specific HM findings.
The following FU-related activities were accounted for: in-clinic consultations, patients contact, discussion with colleague physician, nurse or technician and arranging in clinic consultation. In HM patients, two additional HM-related FU activities were taken into account: 1) checking the website of BIOTRONIK HM Service Center, and 2) checking HM-related emails and faxes (provided by BIOTRONIK HM Service Center)..
Several tools were made available to document the time that physicians, nurses and technicians spend with these FU activities without disrupting their clinical routine much:
- designated case report forms
- a web-based time measurements software.
A user manual for time measurements was handed out to physicians, nurses and technicians to recommend which tool should be used in which clinical situation. The average time per patient followed according to the traditional FU model and the average time per patient followed by the HM-based FU model will be calculated for each of the three health care professionals considered (physicians, nurses and technicians). The difference in costs between the traditional and the HM-based FU will be assessed for statistical significance.
This trial may provide data warranting a change in the guidelines for the use of ICD and CRT-D devices featuring HM function, in that HM may justify a prolongation of the time interval between statutory routine in-clinic FU visits. Coupled with the fact that the information provided by HM helps physicians to recognize some otherwise unsuspected needs for additional FU visits, this may ultimately result in better and more cost-effective health care for all parts involved (patients, providers and payers).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Brussels, Belgium
- Heart Rhythm Management Institute, Free University of Brussels
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Genk, Belgium
- Ziekenhuis Oost Limburg, Campus St. Jan
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Hasselt, Belgium
- Jessa Ziekenhuis (Campus Virga Jesse)
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Leuven, Belgium
- ZU Gasthuisberg
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Oulu, Finland, 90014
- University of Oulu
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Aue, Germany, 08280
- Helios Klinikum Aue
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Berlin, Germany, 10117
- Charité Berlin Campus Mitte
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Leipzig, Germany, 04129
- Städt. Klinikum St. Georg gGmbH
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Leipzig, Germany
- Herzzentrum Leipzig, Abteilung Rhythmologie
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Leiden, Netherlands, 2333
- Leiden Universitair Medisch Centrum
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La Paz, Spain
- Hospital Universitario La Paz
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Madrid, Spain
- Hospital Universitario Puerta de Hierro Majadahonda
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Tenerife, Spain
- Hospital Ntra.Sra.de la Candelaria
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Vigo, Spain
- Arrythmia Unit, Complejo Hospitalario de Vigo (Hospital Xeral)
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Aberdeen, United Kingdom
- Cardiology, Aberdeen Royal Infirmary
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Chertsey, United Kingdom
- Cardiology, St. Peters Hospital/St. George's
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Inverness, United Kingdom
- Cardiology; Raigmore Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
ICD Patient Population - Inclusion Criteria
- Indication for 1-/2- chamber ICD implantation, including replacement indication
- Patient is willing and able to comply with the clinical investigation plan and has provided written informed consent
ICD Patient Population - Exclusion Criteria
- Patients with contraindication to ICD implantation
- Patients with indication for cardiac resynchronization (CRT)
- Minors and pregnant women
- Patients participating in another study
CRT-D Patient Population - Inclusion Criteria
- Patients with indication for de novo CRT-D implantation according to current guidelines
- Patient is willing and able to comply with the clinical investigation plan and has provided written informed consent
CRT-D Patient Population - Exclusion Criteria
- Patients who had a cardiac device implanted before (upgrade, device replacement)
- Life expectancy less than 12 months
- Planned heart transplantation
- NYHA IV
- Minors < 18 years
- Pregnant and breast-feeding women
- Participation in another clinical study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1 = Home Monitoring
Remote monitoring of ICD and CRT-D function and patient status
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Remote monitoring of ICD and CRT-D function and patient status may result in more effective follow-up and increased patient safety
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ACTIVE_COMPARATOR: 2 = No Home Monitoring
Home Monitoring option is switched off
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Home Monitoring option is switched off (in the same kind of devices as used in the other study arm).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Euro spent to follow up ICD and CRT-D patients
Time Frame: 26 months
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26 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Average number of in-hospital follow-up visits per patient
Time Frame: 26 months
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26 months
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Time to first in-hospital follow-up visit beyond the first post-implantation visit
Time Frame: 12 months
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12 months
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Effective financial impact on hospitals / physicians
Time Frame: 26 months
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26 months
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Proportion of in-hospital consultations with relevant findings (i.e. necessitating changes in medical therapy, device programming or re-hospitalisations/ interventions)
Time Frame: 26 months
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26 months
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Proportion of patients with HM-triggered interventions that, without remote monitoring, would have first been discovered at a subsequent scheduled follow-up
Time Frame: 26 months
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26 months
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Incidence of inappropriate ICD shocks
Time Frame: 26 months
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26 months
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Changes in quality-of-life (SF-36) from baseline to the 12- and to 24-month follow-up visits
Time Frame: 26 months
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26 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Hein Heidbüchel, Prof. Dr., ZU Gasthuisberg, Leuven, Belgium
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS043
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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