NCT06823583 Multi-Site Feasibility Testing of the Ventricular Assist Device Anticipatory Guidance Tool
| NCT ID | NCT06823583 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bryan Heart |
| Condition | Ventricular Assist Device |
| Study Type | OBSERVATIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-08-17 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10 participants in total. It began in 2025-08-17 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: (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) Exclusion Criteria: * Not scheduled for VAD surgery * Non English speaking * \<19 yrs of age (Not a VAD Clinician for the clinician evaluation process)
Contact & Investigator
Mathue Baker, MD
STUDY CHAIR
Bryan Heart
Frequently Asked Questions
Who can join the NCT06823583 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Ventricular Assist Device. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06823583 currently recruiting?
Yes, NCT06823583 is actively recruiting participants. Contact the research team at sarah.schroeder@bryanheart.com for enrollment information.
Where is the NCT06823583 trial being conducted?
This trial is being conducted at Lincoln, United States, Milwaukee, United States.
Who is sponsoring the NCT06823583 clinical trial?
NCT06823583 is sponsored by Bryan Heart. The principal investigator is Mathue Baker, MD at Bryan Heart. The trial plans to enroll 10 participants.