Pulse Wave Analysis in Advanced Heart Failure

NCT01642927 | Withdrawn

• 1 other identifier: FWA00000312-7
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

LVAD; IABP; Heart Failure; Thrombosis; Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Observation of pulse wave signatures in LVAD patients

  ongoing

Study Arms (7)

Intra-Aortic Balloon Pump (IABP) Group

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

IABP/LVAD Group

Post-LVAD surgical patients with IABP

Post-LVAD Group

LVAD patients 3 months or greater post-implantation undergoing echocardiography

LVAD Event Group

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

Arrhythmia group

LVAD patient with an irregular heartbeat.

Valvular disease group

LVAD patient with valvular heart disease

Normal control group

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Advanced heart failure patients, eligible for or currently treated with LVAD, outpatient cardiology clinic or inpatient heart failure service patients

You may qualify if:

• )18 years of age or older
• )Advanced heart failure as defined by need for IABP or LVAD
• )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
• )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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Univeristy of Minnesota Lillehei Heart Institute

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Heart Failure; Thrombosis; Hemorrhage

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Eckman, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2012
• First Posted: July 17, 2012
• Study Start: February 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 7, 2023

Record last verified: 2023-04

Locations

US (1)