Pulse Wave Analysis in Advanced Heart Failure

Heart Failure Clinical Trial

— PWA-HF  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01642927
• Other study ID #: FWA00000312-7
• Status: Withdrawn
• Start date: February 2012
• Est. completion date: December 2016

Study information

• Verified date: April 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Univeristy of Minnesota Lillehei Heart Institute	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observation of pulse wave signatures in LVAD patients		ongoing