Optimizing Continuous-flow Left Ventricular Assist Device Settings and Identification of Pump Malfunction - A Comparative Study of Echocardiography and Invasive Hemodynamics
NCT ID: NCT01851889
Last Updated: 2015-10-28
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
15 participants
OBSERVATIONAL
2013-04-30
2015-10-31
Brief Summary
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The hypothesis of the study is that pulmonary capillary wedge pressure (PCWP) will change independently of left ventricular end diastolic diameter (LVEDD) when increasing pump speed ie ΔPCWP/RPM ≠ ΔLVEDD/RPM.
The primary combined endpoint of the study is correlation between ΔPCWP and LVEDD slope under ramp testing in a cohort of "continuous-flow left ventricular assist device" heart failure patients.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CF-LVAD pump speed.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age \> 18 years.
* Heart failure in stable phase without the need for intravenous inotropic therapy.
* Ischemic or non-ischemic cardiomyopathy.
* Signed informed consent.
Exclusion Criteria
* Current hospitalization.
* Implantation of HM II less than one month ago.
18 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Finn Gustafsson
DMSc, Ph.d., Chief Physician.
Principal Investigators
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Mette H Jung, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiology B, University Hospital Rigshospitalet.
Finn Gustafsson, MD, DMSc, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiology B, University Hospital Rigshospitalet.
Locations
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University Hospital Rigshospitalet.
Copenhagen, Kbh Oe, Denmark
Countries
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Other Identifiers
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H-3-2013-010
Identifier Type: -
Identifier Source: org_study_id
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