Recruiting

Anticipatory Guidance

Sponsor:

Bryan Heart

Code:

NCT06823583

Conditions

Ventricular Assist Device

Advanced Heart Failure

Anticipatory Guidance

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Ventricular Assist Device

Advanced Heart Failure

Anticipatory Guidance

Study ID

NCT06823583

Start date

Aug 17, 2025

Status verified date

Sep, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Arms

VAD Clinician Cohort

Up to four VAD Clinicians at each of the three participating sites (a maximum total of 12) will provide feedback and evaluation of the VAD AG Tool v5.0 following consenting.

VAD Patient Cohort

Each of the three sites will enroll a minimum of 3 patients and no more than 5 potential VAD patients (total of 21 for the three sites) to provide evaluation and feedback of accuracy and feasibility of the VAD AG Tool v5.0, occurring at 3-, 6- and 12-months following VAD implant. All patient participants following consenting, will receive the tool pre-surgery and provide evaluation and guidance post surgery, along with de-identifiable demographic and clinic data.

Primary outcome measure

  • Clinician perspectives [ Time Frame: First two weeks of study initiation. ]

Central Contacts and Locations

Central contacts

Sarah E Schroeder, PhD, MSN, BSN, RN-Diploma

402-481-8450sarah.schroeder@bryanheart.com

Kristin Sandau, PhD, RN

612-625-0186KSandau@umn.edu

Locations

Bryan Heart

Recruiting

Lincoln, Nebraska, United States, 68506

Contacts

Sarah E Schroeder, PhD, MSN, BSN, RN

4024833333sarah.schroeder@bryanheart.com

More Information

Sponsor

Bryan Heart

Last update posted

Sep 19, 2025

Last verified

Sep, 2025

Keywords

  • expectations
  • VAD
  • Advanced Heart Failure
  • Anticipatory Guidance
  • quality of life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bryan Heart on 2025-09-19.