Pulse Wave Analysis in Advanced Heart Failure

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

Detailed Description
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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.

Official Title
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Pulse Wave Analysis in Advanced Heart Failure Patients Before and After Ventricular Assist Device

Conditions
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Left Ventricular Assist Device, Heart Failure, Intra-aortic Balloon Pump, LVAD Clot, LVAD-related GI Bleed

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intra-Aortic Balloon Pump (IABP) Group<br>Advanced Heart Failure and/or pre-LVAD surgical patient with IABP | |
| IABP/LVAD Group<br>Post-LVAD surgical patients with IABP | |
| Post-LVAD Group<br>LVAD patients 3 months or greater post-implantation undergoing echocardiography | |
| LVAD Event Group<br>LVAD patients who have developed LVAD thrombosis or GI hemorrhage related to LVAD | |
| Arrhythmia group<br>LVAD patient with an irregular heartbeat. | |
| Valvular disease group<br>LVAD patient with valvular heart disease | |
| Normal control group<br>Healthy participant without any known heart disease (Control group). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observation of pulse wave signatures in LVAD patients |  | ongoing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LVAD, IABP, Heart Failure, Thrombosis, Hemorrhage