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

22:00 EST 19th December 2014 | BioPortfolio

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)

Study Design

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

Conditions

Heart Failure

Intervention

Intrathoracic impedance measurement

Location

RWTH Medizinische Klinik I Aachen
Aachen
Germany

Status

Recruiting

Source

Biotronik SE & Co. KG

Results (where available)

View Results

Links

Clinical Trials [1209 Associated Clinical Trials listed on BioPortfolio]

Does Lung Impedance Correlate With Changes in BNP in Stable and Acutely Decompensated Heart Failure Patients?

The purpose of this study is to determine whether there is a relationship between serial B-natriuretic peptide (BNP) and implantable device measured intrathoracic impedance in symptomatic ...

Optivol Diagnostic Data for Discharge in Heart Failure

The objective of this study is to evaluate whether the heart rate variability, daily heart rate, and/or intrathoracic impedance recorded by implantable cardiac devices can be used in conju...

Clinical Usefulness and Efficacy of Intrathoracic Impedance Monitoring Using the OptiVol Patient Alert(TM)

In this study we investigate the clinical value and efficacy of OptiVol (TM) impedance measurements by Medtronic (R) ICD's. We aim to determine sensitivity and positive predictive value fo...

CRT-D Based Impedance Monitoring Study

The intent of this feasibility study is to collect and analyze intra-thoracic impedance measurements from a CRT-D device in a heart failure population.

PREVENT-HF: Prevention of Heart Failure Events With Impedance Cardiography Testing

The purpose of this study is to determine whether outpatient therapeutic management guided by impedance cardiography (ICG), in addition to standard clinical assessment, will result in a lo...

PubMed Articles [10682 Associated PubMed Articles listed on BioPortfolio]

Predictive impact of the decreasing rate of intrathoracic impedance in worsening chronic heart failure.

Intrathoracic impedance monitoring is useful for heart failure (HF) management in patients with cardiac resynchronization therapy (CRT). However, more accurate identification of worsening chronic HF (...

Worsening Thoracic Impedance as a Ventricular Tachyarrhythmia Risk.

The use of heart failure classification to identify patients with systolic dysfunction who are at risk for ventricular tachyarrhythmias (VAs), sudden cardiac death, and shocks from implantable cardiov...

Thoracic impedance measures tissue characteristics in the vicinity of the electrodes, not intervening lung water: implications for heart failure monitoring.

The rationale for intrathoracic impedance (Z) detection of worsening heart failure (HF) presupposes that changes in Z reflect changes in pulmonary congestion, but is confounded by poor specificity in ...

Derivation of baseline lung impedance in chronic heart failure patients: use for monitoring pulmonary congestion and predicting admissions for decompensation.

The instantaneous lung impedance (ILI) is one of the methods to assess pulmonary congestion or edema (PCE) in chronic heart failure (CHF) patients. Due to usually existing PCE in CHF patients when eva...

Correlation between trans and intra-thoracic impedance and conductance in patients with chronic heart failure.

In chronic heart failure, changes of intra-thoracic impedance (Z0IT) may suggest impending pulmonary congestion; a similar result has been found by measuring trans-thoracic conductance (TFCTT = 1/...

Medical and Biotech [MESH] Definitions

Objective tests of middle ear function based on the difficulty (impedance) or ease (admittance) of sound flow through the middle ear. These include static impedance and dynamic impedance (i.e., tympanometry and impedance tests in conjunction with intra-aural muscle reflex elicitation). This term is used also for various components of impedance and admittance (e.g., compliance, conductance, reactance, resistance, susceptance).

A heterogeneous condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body. Heart failure can be caused by structural defects, functional abnormalities (VENTRICULAR DYSFUNCTION), or a sudden overload beyond its capacity. Chronic heart failure is more common than acute heart failure which results from sudden insult to cardiac function, such as MYOCARDIAL INFARCTION.

Enlargement of the HEART, usually indicated by a cardiothoracic ratio above 0.50. Heart enlargement may involve the right, the left, or both HEART VENTRICLES or HEART ATRIA. Cardiomegaly is a nonspecific symptom seen in patients with chronic systolic heart failure (HEART FAILURE) or several forms of CARDIOMYOPATHIES.

A type of impedance plethysmography in which bioelectrical impedance is measured between electrodes positioned around the neck and around the lower thorax. It is used principally to calculate stroke volume and cardiac volume, but it is also related to myocardial contractility, thoracic fluid content, and circulation to the extremities.

Heart failure caused by abnormal myocardial contraction during SYSTOLE leading to defective cardiac emptying.

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