Pulse Wave Analysis in Advanced Heart Failure

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01642927

Acronym

PWA-HF

Enrollment

Registered

2012-07-17

Start date

2012-02-29

Completion date

2016-12-31

Last updated

2023-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

LVAD, IABP, Heart Failure, Thrombosis, Hemorrhage

Brief summary

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

Detailed 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: 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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

1. Clinical status will not permit pause of IABP (IABP and IABP/LVAD Groups) 2. Unable to undergo echo or oversewn or patched aortic valve (Post-LVAD Group)

Design outcomes

Primary

Measure	Time frame
Observation of pulse wave signatures in LVAD patients	ongoing

Countries

United States

Outcome results