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

September 25, 2012 updated by: Biotronik SE & Co. KG

Monitoring of Fluid Status in Heart Failure Patients by Intrathoracic Impedance Measurement

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

303

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany
        • RWTH Medizinische Klinik I Aachen
      • Aschaffenburg, Germany
        • Klinikum Aschaffenburg
      • Bad Nauheim, Germany
        • Kerckhoff-Klinik GmbH Bad Nauheim
      • Bad Neustadt a. d. Saale, Germany
        • Herz- und Gefäß-Klinik GmbH Bad Neustadt
      • Bad Oeynhausen, Germany
        • HDZ Bad Oeynhausen NRW
      • Berlin, Germany
        • Universitatsklinikum Benjamin Franklin
      • Bochum, Germany
        • Berufsgenossenschaftliche Kliniken Bergmannsheil Universität Bochum
      • Breitenbrunn, Germany
        • Kliniken Erlabrunn gGmbH
      • Düsseldorf, Germany
        • Evangelisches Krankenhaus Düsseldorf
      • Essen, Germany
        • Universitätsklinikum Essen
      • Greifswald, Germany
        • Ernst-Moritz-Arndt Universität Greifswald
      • Hamburg, Germany
        • Asklepios Klinik St. Georg
      • Hamburg, Germany
        • Universitätsklinikum Hamburg - Eppendorf
      • Hannover, Germany
        • Medizinische Hochschule Hannover
      • Heidelberg, Germany
        • Medizinische Universitatsklinik Heidelberg
      • Jena, Germany
        • Universitätsklinikum Jena
      • Neuss, Germany
        • Städtische Kliniken Neuss -Lukaskrankenhaus- GmbH
      • Osnabrück, Germany
        • Marienhospital Osnabrück GmbH
      • Papenburg, Germany
        • Marienkrankenhaus Papenburg-Aschendorf GmbH
      • Saarlouis, Germany
        • St. Elisabeth Klinik Saarlouis
      • Speyer, Germany
        • Krankenhaus der Evangelischen Diakonissenanstalt
      • Tübingen, Germany
        • Universitätsklinikum Tübingen
      • Villingen, Germany
        • Kliniken Villingen
      • Würzburg, Germany
        • Universitätsklinikum Würzburg
  • Spain
      • Burgos, Spain
        • Hospital General Yagüe
      • Donostia - San Sebastian, Spain
        • Hospital de Donostia
      • Valencia, Spain
        • Hospital General Universitario Valencia
  • Switzerland
      • Lugano, Switzerland
        • Cardio Centro Ticino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Study will last until 35 heart failure events are collected

Secondary Outcome Measures

Outcome Measure
Time Frame
Further improvement of the Heart Failure Monitor based on collected data
Time Frame: The same as for primary outcome measure
The same as for primary outcome measure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik SE & Co. KG

Investigators

  • Study Chair: Sebastian Maier, PD Dr. med., Medizinische Klinik und Poliklinik I Universitätsklinikum Würzburg, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

July 7, 2008

First Submitted That Met QC Criteria

July 7, 2008

First Posted (Estimate)

July 8, 2008

Study Record Updates

Last Update Posted (Estimate)

September 26, 2012

Last Update Submitted That Met QC Criteria

September 25, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TA083
  • There is no secondary ID

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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