Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 11:56 PM
Study NCT ID:
NCT00711360
Status:
COMPLETED
Last Update Posted:
2012-09-26
First Post:
2008-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitoring of Fluid Status in Heart Failure Patients by Intrathoracic Impedance Measurement (HomeCARE II)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 303}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-25', 'studyFirstSubmitDate': '2008-07-07', 'studyFirstSubmitQcDate': '2008-07-07', 'lastUpdatePostDateStruct': {'date': '2012-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': 'Study will last until 35 heart failure events are collected'}], 'secondaryOutcomes': [{'measure': 'Further improvement of the Heart Failure Monitor based on collected data', 'timeFrame': 'The same as for primary outcome measure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['heart failure', 'implantable cardioverter-defibrillator', 'intrathoracic impedance', 'cardiac resynchronization therapy', 'home monitoring'], 'conditions': ['Heart Failure', 'Arrhythmias, Cardiac']}, 'referencesModule': {'references': [{'pmid': '30739055', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nLumax 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.\n\nFurthermore, 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).\n\nThe 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.\n\nThe implantation of an ICD is a symptomatic therapy with the following objectives:\n\n* Termination of spontaneous ventricular fibrillation (VF) through shock delivery\n* 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\n* Cardiac resynchronization by multisite ventricular pacing (triple-chamber implant)\n* Compensation of bradycardia through ventricular (single-chamber implant) or atrioventricular sequential pacing (dual- and triple-chamber implant)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* NYHA-class II to IV\n* LVEF lower or equal to 35%\n* Patient accepts Home Monitoring concept and has sufficient GSM/GPRS net coverage\n* Increased risk for HF-related hospitalization according to pre-defined criteria\n* Patient information\n* Informed consent\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Contraindication for ICD implantation\n* Post HTX or actively listed for HTX\n* Cardiac surgery within the previous 3 months or planned at time of inclusion\n* Acute coronary syndrome within the previous 3 months\n* Chronic renal dialysis\n* Pregnant or breast-feeding women\n* Limited contractual capability\n* Participation in another study\n* Anticipated non-compliance with the follow-up scheme\n* Life expectancy not longer than 1.5 years due to a non-cardiac disease'}, 'identificationModule': {'nctId': 'NCT00711360', 'acronym': 'HomeCARE II', 'briefTitle': 'Monitoring of Fluid Status in Heart Failure Patients by Intrathoracic Impedance Measurement (HomeCARE II)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotronik SE & Co. KG'}, 'officialTitle': 'Monitoring of Fluid Status in Heart Failure Patients by Intrathoracic Impedance Measurement', 'orgStudyIdInfo': {'id': 'TA083'}, 'secondaryIdInfos': [{'id': 'There is no secondary ID'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Intrathoracic impedance measurement', 'type': 'DEVICE', 'description': 'Intrathoracic impedance measurement by cardiac resynchronization therapy (CRT) devices and implantable cardioverter defibrillators (ICDs) (Lumax 540)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aachen', 'country': 'Germany', 'facility': 'RWTH Medizinische Klinik I Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'city': 'Aschaffenburg', 'country': 'Germany', 'facility': 'Klinikum Aschaffenburg', 'geoPoint': {'lat': 49.97704, 'lon': 9.15214}}, {'city': 'Bad Nauheim', 'country': 'Germany', 'facility': 'Kerckhoff-Klinik GmbH Bad Nauheim', 'geoPoint': {'lat': 50.36463, 'lon': 8.73859}}, {'city': 'Bad Neustadt A. D. Saale', 'country': 'Germany', 'facility': 'Herz- und Gefäss-Klinik GmbH Bad Neustadt'}, {'city': 'Bad Oeynhausen', 'country': 'Germany', 'facility': 'HDZ Bad Oeynhausen NRW', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Universitätsklinikum Benjamin Franklin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bochum', 'country': 'Germany', 'facility': 'Berufsgenossenschaftliche Kliniken Bergmannsheil Universität Bochum', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'city': 'Breitenbrunn', 'country': 'Germany', 'facility': 'Kliniken Erlabrunn gGmbH', 'geoPoint': {'lat': 50.47553, 'lon': 12.76649}}, {'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Evangelisches Krankenhaus Düsseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Essen', 'country': 'Germany', 'facility': 'Universitätsklinikum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Greifswald', 'country': 'Germany', 'facility': 'Ernst-Moritz-Arndt Universität Greifswald', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Asklepios Klinik St. Georg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Hamburg - Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Medizinische Universitätsklinik Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'city': 'Jena', 'country': 'Germany', 'facility': 'Universitätsklinikum Jena', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'city': 'Neuss', 'country': 'Germany', 'facility': 'Städtische Kliniken Neuss -Lukaskrankenhaus- GmbH', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}, {'city': 'Osnabrück', 'country': 'Germany', 'facility': 'Marienhospital Osnabrück GmbH', 'geoPoint': {'lat': 52.27264, 'lon': 8.0498}}, {'city': 'Papenburg', 'country': 'Germany', 'facility': 'Marienkrankenhaus Papenburg-Aschendorf GmbH', 'geoPoint': {'lat': 53.07769, 'lon': 7.41516}}, {'city': 'Saarlouis', 'country': 'Germany', 'facility': 'St. Elisabeth Klinik Saarlouis', 'geoPoint': {'lat': 49.31366, 'lon': 6.75154}}, {'city': 'Speyer', 'country': 'Germany', 'facility': 'Krankenhaus der Evangelischen Diakonissenanstalt', 'geoPoint': {'lat': 49.32083, 'lon': 8.43111}}, {'city': 'Tübingen', 'country': 'Germany', 'facility': 'Universitätsklinikum Tübingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'city': 'Villingen', 'country': 'Germany', 'facility': 'Kliniken Villingen', 'geoPoint': {'lat': 50.50447, 'lon': 8.93609}}, {'city': 'Würzburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Würzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'city': 'Burgos', 'country': 'Spain', 'facility': 'Hospital General Yagüe', 'geoPoint': {'lat': 42.34106, 'lon': -3.70184}}, {'city': 'Donostia / San Sebastian', 'country': 'Spain', 'facility': 'Hospital de Donostia', 'geoPoint': {'lat': 43.31283, 'lon': -1.97499}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital General universitario Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Lugano', 'country': 'Switzerland', 'facility': 'Cardio Centro Ticino', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}], 'overallOfficials': [{'name': 'Sebastian Maier, PD Dr. med.', 'role': 'STUDY_CHAIR', 'affiliation': 'Medizinische Klinik und Poliklinik I Universitätsklinikum Würzburg, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotronik SE & Co. KG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}