Monitoring of Fluid Status in Heart Failure Patients by Intrathoracic Impedance Measurement (HomeCARE II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT00711360
First received: July 7, 2008
Last updated: September 25, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Heart Failure
Arrhythmias, Cardiac
Device: Intrathoracic impedance measurement
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Monitoring of Fluid Status in Heart Failure Patients by Intrathoracic Impedance Measurement

Resource links provided by NLM:


Further study details as provided by Biotronik SE & Co. KG:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Further improvement of the Heart Failure Monitor based on collected data [ Time Frame: The same as for primary outcome measure ] [ Designated as safety issue: No ]

Enrollment: 303
Study Start Date: July 2008
Study Completion Date: September 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Intrathoracic impedance measurement
    Intrathoracic impedance measurement by cardiac resynchronization therapy (CRT) devices and implantable cardioverter defibrillators (ICDs) (Lumax 540)
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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00711360

Locations
Germany
RWTH Medizinische Klinik I Aachen
Aachen, Germany
Klinikum Aschaffenburg
Aschaffenburg, Germany
Kerckhoff-Klinik GmbH Bad Nauheim
Bad Nauheim, Germany
Herz- und Gefäss-Klinik GmbH Bad Neustadt
Bad Neustadt a. d. Saale, Germany
HDZ Bad Oeynhausen NRW
Bad Oeynhausen, Germany
Universitätsklinikum Benjamin Franklin
Berlin, Germany
Berufsgenossenschaftliche Kliniken Bergmannsheil Universität Bochum
Bochum, Germany
Kliniken Erlabrunn gGmbH
Breitenbrunn, Germany
Evangelisches Krankenhaus Düsseldorf
Düsseldorf, Germany
Universitätsklinikum Essen
Essen, Germany
Ernst-Moritz-Arndt Universität Greifswald
Greifswald, Germany
Universitätsklinikum Hamburg - Eppendorf
Hamburg, Germany
Asklepios Klinik St. Georg
Hamburg, Germany
Medizinische Hochschule Hannover
Hannover, Germany
Medizinische Universitätsklinik Heidelberg
Heidelberg, Germany
Universitätsklinikum Jena
Jena, Germany
Städtische Kliniken Neuss -Lukaskrankenhaus- GmbH
Neuss, Germany
Marienhospital Osnabrück GmbH
Osnabrück, Germany
Marienkrankenhaus Papenburg-Aschendorf GmbH
Papenburg, Germany
St. Elisabeth Klinik Saarlouis
Saarlouis, Germany
Krankenhaus der Evangelischen Diakonissenanstalt
Speyer, Germany
Universitätsklinikum Tübingen
Tübingen, Germany
Kliniken Villingen
Villingen, Germany
Universitätsklinikum Würzburg
Würzburg, Germany
Spain
Hospital General Yagüe
Burgos, Spain
Hospital de Donostia
Donostia - San Sebastian, Spain
Hospital General universitario Valencia
Valencia, Spain
Switzerland
Cardio Centro Ticino
Lugano, Switzerland
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
Study Chair: Sebastian Maier, PD Dr. med. Medizinische Klinik und Poliklinik I Universitätsklinikum Würzburg, Germany
  More Information

No publications provided

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT00711360     History of Changes
Other Study ID Numbers: TA083, There is no secondary ID
Study First Received: July 7, 2008
Last Updated: September 25, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Biotronik SE & Co. KG:
heart failure
implantable cardioverter-defibrillator
intrathoracic impedance
cardiac resynchronization therapy
home monitoring

Additional relevant MeSH terms:
Heart Failure
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014