An observational study in Ventricular Assist Device, Advanced Heart Failure and Anticipatory Guidance, sponsored by Bryan Heart. Recruiting at 2 sites in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by Bryan Heart · Observational
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.
Advanced heart failure (HF) accounts for up to 10% of the overall HF population, and is demonstrated through increased hospitalizations, worsening shortness of breath and decrease in energy. A left ventricular assist device (VAD) and/or cardiac transplantation are promising surgical options to treat advanced HF beyond traditional guideline driven medical therapy, however not always designed for everyone. There are extensive educational materials available preoperatively designed to provide additional information to ease the decision-making process when receiving a VAD, yet most of this material is used to help decide on whether to get a VAD and has less to do with what to expect following a VAD. No information exists to date on describing expectations and outcomes at various time points following VAD. Anticipatory guidance (AG) models primarily exist in the pediatric populations to help parents and caregivers understand the "typical" milestones of what to expect. There are scarce AG models available for adults with chronic comorbid conditions, such as HF. An AG tool specific to VAD patients would be beneficial as preoperative education for potential VAD patients to help better understand the more commonly defined expectations of outcomes beyond adverse event risks, and in turn, hopefully decreases anxiety and depression post-VAD implant, improve domains of health-related quality of life (HRQoL), and decrease hospitalizations.
The Phase 1 study evaluated the development of a prototype AG tool from both longitudinal data analyzed from internal "Quality of Life with a Left Ventricular Assist Device" (QoLVAD) questionnaires that were previously completed as part of a local program's database, and from additional supporting literature. The prototype AG tool has undergone a two-part Delphi method evaluation by 10 international VAD clinicians, and necessary modifications were made based upon results from the two-part Delphi method. An additional round of Delphi method evaluation with local VAD patients was completed with final modifications to reflect the responses from the VAD patients to develop the "VAD AG Tool v5.0". The Phase 2 tool will be referred to as the "VAD AG tool v5.0".
For this phase 2 study, the purpose is to evaluate the VAD AG tool v5.0 across three VAD implanting centers in the United States, with the perspectives of both VAD patients and clinicians. This will be accomplished through four aims: 1. Evaluate clinician perspectives of the VAD AG Tool v5.0; 2. Preoperative distribution of the VAD AG tool v5.0 for consented participants across three VAD implanting centers, to read preoperatively, and evaluate at postoperative time points (3, 6 and 12-months); 3. Describe postoperative VAD patient perceptions of VAD AG tool v5.0 at three time points (3, 6, and 12-months); and 4. Evaluate relationships between HRQoL and the following: anxiety, depression, cognition, and hospital readmissions.
This is the only study on the registry with Bryan Heart as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Advanced heart failure patients will be approached by their internal VAD teams who have been scheduled for a VAD implantation. Only age requirement is >/= 19 as the age of majority in most states for consenting is 19. The goal is to consent consecutively so as to limit selection bias as much as able to. This is a feasibility study so consecutive approaching is key.
(For patient inclusion):
(-VAD clinician for the clinician evaluation process)
Exclusion Criteria:
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.
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.
Clinician perspectives
Evaluate clinician perspectives of the Ventricular Assist Device Anticipatory Guidance Tool (VAD AG Tool) v5.0 for accuracy, by completing an evaluation where each item will be scored 1-4, as follows: 1 Not Relevant, 2 Somewhat Relevant, 3 Quite Relevant, 4 Highly Relevant
Time frame: First two weeks of study initiation.
Distribution of the Ventricular Assist Device Anticipatory Guidance Tool (VAD AG Tool) v5.0
Each site investigator will validate that the Ventricular Assist Device Anticipatory Guidance Tool (VAD AG Tool) v5.0 was preoperatively distributed.
Time frame: 12 months
Postoperative patient perceptions of Ventricular Assist Device Anticipatory Guidance Tool (VAD AG Tool) v5.0
Consented patients will provide prospectives of the Ventricular Assist Device Anticipatory Guidance Tool (VAD AG Tool) v5.0, through a patient evaluation form where all tool items will be scored on a 1-4 scale, where 1 is Not Important, 2 is Somewhat Important, 3 is Quite Important, 4 is Highly Important
Time frame: 12 months
Complete post-operative Quality of Life with a Left Ventricular Assist Device (QoLVAD)
All consented participants will complete the QoLVAD questionnaire at three time points (3-6-12 months)
Time frame: 12 months
Complete post-operative Generalized Anxiety Disorder 7-item scale at three different time points
All consented participants will complete the GAD-7 assessment at three time points (3-6-12 months)
Time frame: 12 months
Complete post-operative Patient Health Questionnaire-9 tool at three different time points
All consented participants will complete the PHQ-9 assessment at three time points (3-6-12 months)
Time frame: 12 months
Complete post-operative Trailmaking B assessment at three different time points
All consented participants will complete the Trailmaking B assessment at three time points (3-6-12 months)
Time frame: 12 months
Plan to share: Yes — Each participant will have de-identifiable demographic and clinical data gathered for the purposes of this study, along with the data obtained from each pre-VAD questionnaire will be gathered by each site PI and provided to the primary study PI. The de-identifiable demographic and clinical data will be entered on the Pre- or Post-operative Data Collection Forms, and copies will be sent directly to the primary study PI. All de-identifiable study data will be stored in a password protected computer at Bryan Heart, located in the primary study PI's Mechanical Circulatory Support office. All data (which will be de-identified) will only be accessible directly by the primary study PI and the co-investigators. No direct identifiable individualized participant data will be shared with the primary study PI or co-investigators as all data that is to be sent will be coded with the site number, the sequence in consenting and the interval form number.
Supporting information: Sap
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.