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
NA
81 participants
INTERVENTIONAL
2013-03-31
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Quadripolar LV electrode
Application of a quadripolar LV electrode
Application of quadripolar / bipolar LV electrodes
Bipolar LV electrode
Application of a bipolar LV electrode
Application of quadripolar / bipolar LV electrodes
Interventions
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Application of quadripolar / bipolar LV electrodes
Eligibility Criteria
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Inclusion Criteria
* Ischemic cardiomyopathy (ICM) or dilated cardiomyopathy (DCM)
* Sinus rhythm
* NYHA II-IV
* Age ≥ 18 years
* Written informed consent to participate in the study
Exclusion Criteria
* Valvular cardiomyopathy
* Patient receiving a non-transvenous LV electrode
* Known pregnancy
* Age \< 18 years
* Life expectancy \< 1 year
* Atrial fibrillation / atrial flutter at the time of enrolment
* Inability to provide informed consent
* Participation in another study with active therapeutic arm
* Regular follow-up in the study center within the first 6 months after implantation not guaranteed
18 Years
85 Years
ALL
No
Sponsors
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Heart and Diabetes Center North-Rhine Westfalia
OTHER
Responsible Party
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Klaus Juergen Gutleben
Senior cardiologist
Principal Investigators
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Klaus-Juergen Gutleben, M.D.
Role: PRINCIPAL_INVESTIGATOR
Heart and Diabetes Center North Rhine-Westphalia, Department of Cardiology
Locations
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Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum
Bad Oeynhausen, , Germany
Countries
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Other Identifiers
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HDZNRW_KA_002_KJG
Identifier Type: -
Identifier Source: org_study_id
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