Status:
COMPLETED
INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients With Remotely Monitored Implanted Cardioverter Defibrillators (ICD) SysTems
Lead Sponsor:
Abbott Medical Devices
Conditions:
Heart Failure
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
It's the aim of this study to analyze the benefit of personal patient / physician contacts in heart failure patients with remotely monitored implanted cardioverter defibrillators (ICD) or ICD with car...
Eligibility Criteria
Inclusion
- Indication for implantation (new, boxchange, upgrade) of ICD/ CRT-D
- Written informed consent
- Ejection Fraction \<= 35%
- New York Heart Association (NYHA) Class I-III
- Age \>=18 and \<=80 years
- In patient's home environment sufficient infrastructure (analog phone line or sufficient strength of GSM (Global System for Mobile communication) mobile phone network) for running a Merlin@home transmitter is available
Exclusion
- Arterio ventricular (AV) Block III / AV Block II Type Mobitz
- Severe renal insufficiency
- Coronary angiology intervention within previous 3 months
- Myocardial infarction within previous month
- Life expectancy \< 1 year
- Expected poor data quality / compliance
- Pregnancy
- Patient is already participating to another study with active therapy arm
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT01200381
Start Date
February 1 2010
End Date
July 1 2014
Last Update
February 4 2019
Active Locations (17)
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1
SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald
Bad Friedrichshall, Germany, 74177
2
Asklepios Klinik Bad Oldesloe
Bad Oldesloe, Germany, 23843
3
Segeberger Kliniken GmbH
Bad Segeberg, Germany, 23795
4
Evangelisches Krankenhaus Bielefeld gGmbH
Bielefeld, Germany, 33617