Monitoring of Fluid Status in Heart Failure Patients by Intrathoracic Impedance Measurement in Japan (J-HomeCARE II)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01221649|
Recruitment Status : Completed
First Posted : October 15, 2010
Last Update Posted : October 12, 2015
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Arrhythmias, Cardiac||Device: ICD/CRT-D||Phase 4|
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 will allow for automatic early detection of imminent decompensation at a presymptomatic stage and immediate initialization of clinical meaningful therapeutic interventions preventing heart failure related hospitalizations. The aim of this investigation is to record long-term impedance trends in heart failure patients with and without HF related events (hospitalizations due to acute decompensation) in order to develop algorithms for device-based early detection and warning of HF deterioration accompanied by pulmonary congestion.
Lumax is the name of a family of implantable ICDs. The primary objective of the therapy is the prevention of sudden cardiac death. The aim is to automatically detect and terminate cardiac arrest caused by ventricular tachyarrhythmia. All major therapeutical approaches from the field of cardiology and electrophysiology are contained within the Lumax family.
Furthermore, the device is capable of treating bradycardia arrhythmias and congestive heart failure. Congestive heart failure is treated with cardiac resynchronization therapy with multisite ventricular pacing known as cardiac resynchronization therapy (CRT).
The integrated Home Monitoring component can provide information about occurring rhythm disturbances and delivered therapies close to real time as well as by intracardiac electrogram (IEGM) Online HD®. Furthermore, statistical data about the patient's condition as well as information about the integrity status of the implant itself are sent.
The implantation of an ICD is a symptomatic therapy with the following objectives:
Termination of spontaneous ventricular fibrillation (VF) through shock delivery Termination of spontaneous ventricular tachycardia (VT) by means of antitachycardia pacing (ATP); in case of ineffective ATP or hemodynamically not tolerated VT with shock delivery Cardiac resynchronization by multisite ventricular pacing (triple-chamber implant) Compensation of bradycardia through ventricular (single-chamber implant) or atrioventricular sequential pacing (dual- and triple-chamber implant)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||198 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Monitoring of Fluid Status in Heart Failure Patients by Intrathoracic Impedance Measurement in Japan|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
- Device: ICD/CRT-D
BIOTRONIK ICD family Lumax 540 and its successors
- HF Events [ Time Frame: 21 months follow-up ]Long-term impedance trends in patients with clinically relevant HF events, to support the development of impedance based detection algorithms. A posterior assessment of sensitivity and false alarm rate of the detection algorithms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01221649
|Kokura Kinen Hospital|
|Kitakyushu, Fukuoka, Japan, 802-8555|
|Yamada Red Cross Hospital|
|Ise, Mie, Japan, 516-0805|
|Hiroshima Shimin Hospital|
|Tokyo Women's Medical University|
|Principal Investigator:||Shoda Morio, DR||Tokyo Women's University Hospital|