Status:
TERMINATED
European Health Economic Trial on Home Monitoring in ICD and CRT-D Patients (EuroEco)
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
Ventricular Fibrillation
Tachycardia, Ventricular
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 effi...
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 an...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 17 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2016
Estimated Enrollment :
409 Patients enrolled
Trial Details
Trial ID
NCT00776087
Start Date
October 17 2008
End Date
October 27 2016
Last Update
July 2 2017
Active Locations (17)
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1
Heart Rhythm Management Institute, Free University of Brussels
Brussels, Belgium
2
Ziekenhuis Oost Limburg, Campus St. Jan
Genk, Belgium
3
Jessa Ziekenhuis (Campus Virga Jesse)
Hasselt, Belgium
4
ZU Gasthuisberg
Leuven, Belgium