Monitoring of Hemodynamics in Heart Failure Patients by Intracardiac Impedance Measurement
NCT ID: NCT01711281
Last Updated: 2015-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
68 participants
INTERVENTIONAL
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Intracardiac Impedance Measurement
Intracardiac Impedance Measurement Algorithm (integrated in CRT-D device)
Interventions
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Intracardiac Impedance Measurement Algorithm (integrated in CRT-D device)
Eligibility Criteria
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Inclusion Criteria
* Planned implantation with a Lumax 740 HF-T device, a bipolar LV-lead and a true bipolar RV-lead
* NYHA class II or III
* QRS ≥ 150 ms
* LVEF between 15% and 35%
* LVEDD ≥ 55 mm
* Evaluable echo measurements
Exclusion Criteria
* Heart surgery within the previous 3 months or planned for the time of study participation; post-heart transplantation or listed for heart transplantation
* Non-ambulatory patients
* Chronic renal dialysis
* Life expectancy less than 1 year due to a non-cardiac disease
* Age \< 18 years and/or limited contractual capability
* Addiction to alcohol, medical drugs or illegal drugs
* Pregnant or breast-feeding women
* Participation in another clinical trial
18 Years
ALL
No
Sponsors
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Biotronik SE & Co. KG
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Sogaard, MD, PhD, Prof.
Role: STUDY_CHAIR
Aalborg University, Aalborg University Hospital
Klaus-Jürgen Gutleben, MD, PhD
Role: STUDY_CHAIR
Herz- und Diabeteszentrum NRW, Bad Oeynhausen
Locations
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Aalborg Sygehus, Kardiologisk Afdeling
Aalborg, , Denmark
Aarhus Universitetshospital, Hjertemedicinsk Afdeling B
Aarhus, , Denmark
Gentofte Hospital, Department P
Hellerup, , Denmark
Odense University Hospital, Hjertemedicinsk Afdeling B
Odense, , Denmark
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, , Germany
Charité Campus Virchow-Klinik, Medizinische Klinik mit Schwerpunkt Kardiologie
Berlin, , Germany
Herzzentrum Brandenburg, Immanuel Klinikum
Bernau, , Germany
Klinikum Bielefeld Mitte
Bielefeld, , Germany
Evangelisches Krankenhaus
Bielefeld, , Germany
Universitätsklinikum Essen, Westdeutsches Herzzentrum Essen
Essen, , Germany
Medizinische Hochschule Hannover, Klinik für Kardiologie und Angiologie
Hanover, , Germany
Kliniken Maria Hilf GmbH, Innere Medizin II, Klinik für Kardiologie
Mönchengladbach, , Germany
Klinikum der Universität München - Grosshadern
München, , Germany
Havellandklinik Nauen
Nauen, , Germany
Krankenhaus Reinbek St. Adolf-Stift, Innere Abt. Kardiologie
Reinbek, , Germany
Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik I, Medizinische Intensiv- und Notfallmedizin
Würzburg, , Germany
Azienda Ospedaliero Univesitaria, Ospedali Riuniti Umberto I- G.M. Lancisi- G. Salesi
Ancona, , Italy
Fondazione Toscana G. Monasterio
Pisa, , Italy
Leiden University Medical Center
Leiden, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
Isala Klinieken, Hospital de Weezenlanden, Department of Cardiology
Zwolle, , Netherlands
Universitätsspital Zürich
Zurich, , Switzerland
Countries
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Other Identifiers
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CR010
Identifier Type: -
Identifier Source: org_study_id
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