Pulse Wave Analysis in Advanced Heart Failure (PWA-HF)

University of Minnesota (UMN)

Status: Withdrawn

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

Study type: Observational

Funder types: Other

Identifiers

NCT01642927

FWA00000312-7

Details and patient eligibility

About

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

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:

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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)

Trial design

0 participants in 7 patient groups

Intra-Aortic Balloon Pump (IABP) Group

Description:

Advanced Heart Failure and/or pre-LVAD surgical patient with IABP

IABP/LVAD Group

Description:

Post-LVAD surgical patients with IABP

Post-LVAD Group

Description:

LVAD patients 3 months or greater post-implantation undergoing echocardiography

LVAD Event Group

Description:

LVAD patients who have developed LVAD thrombosis or GI hemorrhage related to LVAD

Arrhythmia group

Description:

LVAD patient with an irregular heartbeat.

Valvular disease group

Description:

LVAD patient with valvular heart disease

Normal control group

Description:

Healthy participant without any known heart disease (Control group).