Heart Failure Clinical Trial

Pulse Wave Analysis in Advanced Heart Failure

Summary

A comparison of pulse wave characteristics, as measured by peripheral tonometry, in pre and post Left Ventricular Assist Device (LVAD) patients.

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Full Description

Pulse waveforms, especially central pressure waveforms, are predictive of cardiovascular events. Peripheral waveforms have been correlated to central waveforms. Peripheral waveforms can be easily measured through applanation tonometry. In this study the investigators hypothesize:

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.
That temporary changes in LVAD speed will be evident in frequency spectrum analysis of peripheral, non-invasive waveforms.
That clinical events involving LVAD will have characteristic frequency spectra.

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Eligibility Criteria

Inclusion Criteria:

1)18 years of age or older

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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:

Clinical status will not permit pause of IABP (IABP and IABP/LVAD Groups)
Unable to undergo echo or oversewn or patched aortic valve (Post-LVAD Group)

Study is for people with:

Heart Failure

Study ID:

NCT01642927

Recruitment Status:

Withdrawn

Sponsor:

University of Minnesota

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There is 1 Location for this study

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Univeristy of Minnesota Lillehei Heart Institute
Minneapolis Minnesota, 55455, United States

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Study is for people with:

Heart Failure

Study ID:

NCT01642927

Recruitment Status:

Withdrawn

Sponsor:


University of Minnesota

How clear is this clinincal trial information?

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