Characterization of the Plasma Proteome Following Left Ventricular Assist Device Implantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-01-31

Brief Summary

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

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Detailed Description

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Conditions

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Ventricular Dysfunction, Left

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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LVAD recipients

LVAD

Intervention Type DEVICE

Interventions

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LVAD

Intervention Type DEVICE

Other Intervention Names

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HeartMate II

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No