Pulse Wave Analysis in Advanced Heart Failure

Withdrawn

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

• Registration Number: NCT01642927
• Lead Sponsor: University of Minnesota

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-07-12
• Study First Submitted QC: 2012-07-16
• Study First Posted: 2012-07-17
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-06
• Last Update Posted: 2023-04-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Observation of pulse wave signatures in LVAD patients	ongoing

Trial Locations

Locations (1)

Univeristy of Minnesota Lillehei Heart Institute; 🇺🇸 Minneapolis, Minnesota, United States