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| There is no secondary ID |
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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.
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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrathoracic impedance measurement | Device | Intrathoracic impedance measurement by cardiac resynchronization therapy (CRT) devices and implantable cardioverter defibrillators (ICDs) (Lumax 540) |
| Measure | Description | 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. | Study will last until 35 heart failure events are collected |
| Measure | Description | Time Frame |
|---|---|---|
| Further improvement of the Heart Failure Monitor based on collected data | The same as for primary outcome measure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sebastian Maier, PD Dr. med. | Medizinische Klinik und Poliklinik I Universitätsklinikum Würzburg, Germany | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RWTH Medizinische Klinik I Aachen | Aachen | Germany | ||||
| Klinikum Aschaffenburg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30739055 | Derived | 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. |
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| 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 |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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