Status:
COMPLETED
Monitoring of Fluid Status in Heart Failure Patients by Intrathoracic Impedance Measurement in Japan (J-HomeCARE II)
Lead Sponsor:
Biotronik Japan, Inc.
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 ICD family Lumax 540 is capable of measuring the intrathoracic impedance on a daily basis and transmission of impedance trend data via the Home Monitoring technology. In future, this...
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
- New York Heart Association (NYHA)-class II to IV
- Left ventricular ejection fraction (LVEF) lower or equal to 35%
- Patient accepts Home Monitoring concept and has sufficient Global System for Mobile Communications (GSM) /General Packet Radio Service (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 heart transplant (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 :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT01221649
Start Date
June 1 2010
End Date
February 1 2014
Last Update
October 12 2015
Active Locations (4)
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1
Kokura Kinen Hospital
Kitakyushu, Fukuoka, Japan, 802-8555
2
Hiroshima Shimin Hospital
Hiroshima, Hiroshima, Japan
3
Yamada Red Cross Hospital
Ise, Mie-ken, Japan, 516-0805
4
Tokyo Women's Medical University
Tokyo, Tokyo, Japan