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Monitoring of Fluid Status in Heart Failure Patients by Intrathoracic Impedance Measurement (HomeCARE II) (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: NCT00711360
Recruitment Status : Completed
First Posted : July 8, 2008
Last Update Posted : September 26, 2012
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG

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 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.

Condition or disease Intervention/treatment Phase
Heart Failure Arrhythmias, Cardiac Device: Intrathoracic impedance measurement Phase 4

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 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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 303 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure


Intervention Details:
  • Device: Intrathoracic impedance measurement
    Intrathoracic impedance measurement by cardiac resynchronization therapy (CRT) devices and implantable cardioverter defibrillators (ICDs) (Lumax 540)


Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Further improvement of the Heart Failure Monitor based on collected data [ Time Frame: The same as for primary outcome measure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

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


Locations
Show Show 28 study locations
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
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Study Chair: Sebastian Maier, PD Dr. med. Medizinische Klinik und Poliklinik I Universitätsklinikum Würzburg, Germany
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT00711360    
Other Study ID Numbers: TA083
There is no secondary ID
First Posted: July 8, 2008    Key Record Dates
Last Update Posted: September 26, 2012
Last Verified: September 2012
Keywords provided by Biotronik SE & Co. KG:
heart failure
implantable cardioverter-defibrillator
intrathoracic impedance
cardiac resynchronization therapy
home monitoring
Additional relevant MeSH terms:
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Heart Failure
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes