NCT06823583Recruiting
Multi-Site Feasibility Testing of the Ventricular Assist Device Anticipatory Guidance Tool
Source: ClinicalTrials.gov · Last updated 19 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 10 (estimated)
- First submitted
- 12 Jan 2025
- Start date
- 17 Aug 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- Bryan Heart
- Diseases
- Heart failure
- NCT number
- NCT06823583
What you commit to
- Study type: Observational
- Planned participants: 10
- From 17 Aug 2025 to the primary completion date, Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Not scheduled for VAD surgery
Age
- \<19 yrs of age (Not a VAD Clinician for the clinician evaluation process)
Other
- Non English speaking
Who the study is looking for
- (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)
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bryan Heart Coordinator of this site? Confirm its status | Lincoln | United States | Recruiting |
| Advocate Aurora Health Coordinator of this site? Confirm its status | Milwaukee | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.