RecruitingNCT06823583

Multi-Site Feasibility Testing of the Ventricular Assist Device Anticipatory Guidance Tool


Sponsor

Bryan Heart

Enrollment

10 participants

Start Date

Aug 17, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

There are a variety of educational documents available to help in a participant's decision for VAD implant, however there is little information available to potential participants to help understand areas of satisfaction and concern following a VAD implant as various time points. The investigators want to provide better patient care through increased education and awareness beyond surgical outcomes and contribute to patient understanding of "what to expect" following a VAD implant. The investigators have created an anticipatory guidance (AG) tool based upon previous responses recorded in a local program's database, from the Quality of Life with a Left Ventricular Assist Device (QoLVAD) questionnaire. This questionnaire has five different domains (physical, social, emotional, cognitive thinking and spiritual/well-being). Investigators have previously analyzed responses to determine common areas of satisfaction and concern at 3-, 6-, 12- and 24-months post-VAD implant to better understand quality of life when living with a VAD. Investigators have had both VAD clinicians and VAD patients initially evaluate the tool to determine accuracy and effectiveness of the anticipatory guidance (AG) tool.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the safety and usability of a ventricular assist device (VAD) — a mechanical pump that helps a weakened heart push blood through the body — across multiple medical centers. **You may be eligible if...** - You have advanced heart failure that has not responded to standard medications - Your heart function is severely reduced - Your doctor believes you need mechanical heart support - You meet the clinical criteria for VAD implantation at a participating center **You may NOT be eligible if...** - You have serious blood clotting disorders - You have had a recent major stroke - You have severe irreversible kidney or liver failure - You are not able to manage anticoagulation (blood-thinning) therapy at home - You have an active serious infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(2)

Bryan Heart

Lincoln, Nebraska, United States

Advocate Aurora Health

Milwaukee, Wisconsin, United States

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NCT06823583


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