Status:
COMPLETED
Monitoring of Fluid Status in Heart Failure Patients by Intrathoracic Impedance Measurement (HomeCARE II)
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
Heart Failure
Arrhythmias, Cardiac
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The new BIOTRONIK implantable cardioverter defibrillator (ICD) family Lumax 540 is capable of measuring the intrathoracic impedance on a daily basis and transmission of impedance trend data via the Ho...
Detailed Description
The new BIOTRONIK implantable cardioverter defibrillator (ICD) family Lumax 540 is capable of measuring the intrathoracic impedance on a daily basis and transmission of impedance trend data via the Ho...
Eligibility Criteria
Inclusion
- Patient eligible for 1-, 2- or 3-chamber ICD implantation according to current guidelines or patient already implanted with a Lumax 540 device or successor
- NYHA-class II to IV
- LVEF lower or equal to 35%
- Patient accepts Home Monitoring concept and has sufficient GSM/GPRS net coverage
- Increased risk for HF-related hospitalization according to pre-defined criteria
- Patient information
- Informed consent
Exclusion
- Age \< 18 years
- Contraindication for ICD implantation
- Post HTX or actively listed for HTX
- Cardiac surgery within the previous 3 months or planned at time of inclusion
- Acute coronary syndrome within the previous 3 months
- Chronic renal dialysis
- Pregnant or breast-feeding women
- Limited contractual capability
- Participation in another study
- Anticipated non-compliance with the follow-up scheme
- Life expectancy not longer than 1.5 years due to a non-cardiac disease
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
303 Patients enrolled
Trial Details
Trial ID
NCT00711360
Start Date
July 1 2008
End Date
September 1 2012
Last Update
September 26 2012
Active Locations (28)
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1
RWTH Medizinische Klinik I Aachen
Aachen, Germany
2
Klinikum Aschaffenburg
Aschaffenburg, Germany
3
Kerckhoff-Klinik GmbH Bad Nauheim
Bad Nauheim, Germany
4
Herz- und Gefäss-Klinik GmbH Bad Neustadt
Bad Neustadt A. D. Saale, Germany