Characterization of the Plasma Proteome Following Left Ventricular Assist Device Implantation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02428894

Enrollment

Registered

2015-04-29

Start date

2014-10-31

Completion date

2017-01-31

Last updated

2017-07-17

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

Conditions

Ventricular Dysfunction, Left

Brief summary

The purpose of this study is to characterize changes in the plasma proteome over time following left ventricular assist device (LVAD) implantation.

Interventions

DEVICELVAD

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Planned HeartMate II LVAD implantation * Planned warfarin (goal INR, 2.0-3.0) and low-dose aspirin therapy post-LVAD placement

Exclusion criteria

* Prior history of mechanical circulatory support; * Body weight \< 110 lbs; * Pre-existing hemolytic, bleeding, or immunologic disorders prior to LVAD implantation; * Severe aortic stenosis; * Renal failure requiring dialysis; * Hepatic dysfunction resulting in severe coagulopathies; * Recent serious infection; * Current need for prolonged ventilatory support; * Prior organ transplantation; * Blood transfusion within 14 days of the first planned study blood draw; * Concomitant immunosuppressant or chemotherapeutic agents; * Pregnant women; * Decisionally challenged or prisoners; * Unwilling to provide written informed consent

Design outcomes

Primary

Measure	Time frame
Quantitative differences in plasma protein abundance	Days 7, 14, 30, 60, 90, and 180 post-LVAD implantation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026