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

Heart Failure Clinical Trial

— HomeCARE II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00711360
• Other study ID #: TA083
• Secondary ID: There is no seco
• Status: Completed
• Phase: Phase 4
• First received: July 7, 2008
• Last updated: September 25, 2012
• Start date: July 2008
• Est. completion date: September 2012

Study information

• Verified date: September 2012
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: September 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
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	Asklepios Klinik St. Georg	Hamburg
Germany	Universitätsklinikum Hamburg - Eppendorf	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
Spain	Hospital General Yagüe	Burgos
Spain	Hospital de Donostia	Donostia - San Sebastian
Spain	Hospital General universitario Valencia	Valencia
Switzerland	Cardio Centro Ticino	Lugano

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

Germany,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Study will last until 35 heart failure events are collected	No
Secondary	Further improvement of the Heart Failure Monitor based on collected data		The same as for primary outcome measure	No