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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WITHDRAWN
OBSERVATIONAL
2012-02-29
2016-12-31
Brief Summary
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Detailed Description
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1. That previously established peripheral tonometry techniques would apply to patients with advanced heart failure, including continuous flow LVADs and facilitate serial evaluation of central hemodynamics without invasive monitoring.
2. That temporary changes in LVAD speed will be evident in frequency spectrum analysis of peripheral, non-invasive waveforms.
3. That clinical events involving LVAD will have characteristic frequency spectra.
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Intra-Aortic Balloon Pump (IABP) Group
Advanced Heart Failure and/or pre-LVAD surgical patient with IABP
No interventions assigned to this group
IABP/LVAD Group
Post-LVAD surgical patients with IABP
No interventions assigned to this group
Post-LVAD Group
LVAD patients 3 months or greater post-implantation undergoing echocardiography
No interventions assigned to this group
LVAD Event Group
LVAD patients who have developed LVAD thrombosis or GI hemorrhage related to LVAD
No interventions assigned to this group
Arrhythmia group
LVAD patient with an irregular heartbeat.
No interventions assigned to this group
Valvular disease group
LVAD patient with valvular heart disease
No interventions assigned to this group
Normal control group
Healthy participant without any known heart disease (Control group).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2)Advanced heart failure as defined by need for IABP or LVAD
3)One or more of the following:
* Current inpatient heart failure treatment with intra-aortic balloon pump (IABP)-IABP Group
•≤ 1 week post-LVAD implantation with current IABP support-IABP/LVAD Group
•≥ 3 mo post-LVAD placement and scheduled for LVAD speed optimization with echocardiography.-Post-LVAD Group
* Post-LVAD placement with suspected GI hemorrhage or LVAD thrombosis-LVAD Event Group
4)Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Exclusion Criteria
2. Unable to undergo echo or oversewn or patched aortic valve (Post-LVAD Group)
18 Years
ALL
No
Sponsors
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University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Peter Eckman, MD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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Univeristy of Minnesota Lillehei Heart Institute
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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FWA00000312-7
Identifier Type: -
Identifier Source: org_study_id
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