Monitoring of Fluid Status in Heart Failure Patients by Intrathoracic Impedance Measurement (HomeCARE II) (HomeCARE II)
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|ClinicalTrials.gov Identifier: NCT00711360|
Recruitment Status : Completed
First Posted : July 8, 2008
Last Update Posted : September 26, 2012
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Arrhythmias, Cardiac||Device: Intrathoracic impedance measurement||Phase 4|
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 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 heart failure 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 :||303 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|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||September 2012|
- Device: Intrathoracic impedance measurement
Intrathoracic impedance measurement by cardiac resynchronization therapy (CRT) devices and implantable cardioverter defibrillators (ICDs) (Lumax 540)
- Long-term impedance trends in patients with clinically relevant heart failure events, to support the development of impedance based detection algorithms. A posterior assessment of sensitivity and false alarm rate of the detection algorithms. [ Time Frame: Study will last until 35 heart failure events are collected ]
- Further improvement of the Heart Failure Monitor based on collected data [ Time Frame: The same as for primary outcome measure ]
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): NCT00711360
|Study Chair:||Sebastian Maier, PD Dr. med.||Medizinische Klinik und Poliklinik I Universitätsklinikum Würzburg, Germany|