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

Recruiting now

Conditions studied: Ventricular Assist Device, Advanced Heart Failure, Anticipatory Guidance

In brief

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.

Key facts

Study ID

NCT06823583

Run by

Bryan Heart

People needed

10

Starts

2025-08-17

Expected to finish

2026-12-01

Last updated by the study team

2025-09-19

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• (For patient inclusion):
• scheduled for a VAD implantation
• English-speaking as the VAD AG Tool v5.0 has not yet been translated beyond English age ≥19 years at the time of implant as most states in North America have an age of majority for consent signing.
• (-VAD clinician for the clinician evaluation process)

You may not qualify if…

• Not scheduled for VAD surgery
• Non English speaking
• <19 yrs of age (Not a VAD Clinician for the clinician evaluation process)

Where it is running

• Bryan Heart — Lincoln, Nebraska, United States (enrolling)
• Advocate Aurora Health — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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