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

NCT ID: NCT00711360

Last Updated: 2012-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 303 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2012-09-30

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.

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)

Conditions

Heart Failure; Arrhythmias, Cardiac

Keywords

heart failure; implantable cardioverter-defibrillator; intrathoracic impedance; cardiac resynchronization therapy; home monitoring

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Interventions

Intrathoracic impedance measurement

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik SE & Co. KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sebastian Maier, PD Dr. med.

Role: STUDY_CHAIR

Medizinische Klinik und Poliklinik I Universitätsklinikum Würzburg, Germany

Locations

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

Hanover, , 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

Hospital General Yagüe

Burgos, , Spain

Hospital de Donostia

Donostia / San Sebastian, , Spain

Hospital General universitario Valencia

Valencia, , Spain

Cardio Centro Ticino

Lugano, , Switzerland

Countries

Germany; Spain; Switzerland

References

Maier SKG, Paule S, Jung W, Koller M, Ventura R, Quesada A, Bordachar P, Garcia-Fernandez FJ, Schumacher B, Lobitz N, Takizawa K, Ando K, Adachi K, Shoda M. Evaluation of thoracic impedance trends for implant-based remote monitoring in heart failure patients - Results from the (J-)HomeCARE-II Study. J Electrocardiol. 2019 Mar-Apr;53:100-108. doi: 10.1016/j.jelectrocard.2019.01.004. Epub 2019 Jan 25.

Reference Type: DERIVED

PMID: 30739055 (View on PubMed)

Other Identifiers

There is no secondary ID

Identifier Type: -

Identifier Source: secondary_id

TA083

Identifier Type: -

Identifier Source: org_study_id