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

September 15, 2025 updated by: Sarah E Schroeder, Bryan Heart

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kristin Sandau, PhD, RN
  • Phone Number: 612-625-0186
  • Email: KSandau@umn.edu

Study Contact Backup

Study Locations

  • United States
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Not yet recruiting
        • Advocate Aurora Health
        • Contact:
        • Principal Investigator:
          • Riley Rossbach, BSBME

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician perspectives
Time Frame: First two weeks of study initiation.
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
First two weeks of study initiation.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distribution of the Ventricular Assist Device Anticipatory Guidance Tool (VAD AG Tool) v5.0
Time Frame: 12 months
Each site investigator will validate that the Ventricular Assist Device Anticipatory Guidance Tool (VAD AG Tool) v5.0 was preoperatively distributed.
12 months
Postoperative patient perceptions of Ventricular Assist Device Anticipatory Guidance Tool (VAD AG Tool) v5.0
Time Frame: 12 months
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
12 months
Complete post-operative Quality of Life with a Left Ventricular Assist Device (QoLVAD)
Time Frame: 12 months
All consented participants will complete the QoLVAD questionnaire at three time points (3-6-12 months)
12 months
Complete post-operative Generalized Anxiety Disorder 7-item scale at three different time points
Time Frame: 12 months
All consented participants will complete the GAD-7 assessment at three time points (3-6-12 months)
12 months
Complete post-operative Patient Health Questionnaire-9 tool at three different time points
Time Frame: 12 months
All consented participants will complete the PHQ-9 assessment at three time points (3-6-12 months)
12 months
Complete post-operative Trailmaking B assessment at three different time points
Time Frame: 12 months
All consented participants will complete the Trailmaking B assessment at three time points (3-6-12 months)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bryan Heart

Collaborators

International Consortium of Circulatory Assist Clinicians
International Society for Heart and Lung Transplantation

Investigators

  • Study Chair: Mathue Baker, MD, Bryan Heart

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 12, 2025

First Submitted That Met QC Criteria

February 7, 2025

First Posted (Actual)

February 12, 2025

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 15, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCS-VAD-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

August 2025 is the expected start date, and the goal is to have all data collected and back to the primary study PI by November to December 2026 to which no additional data will need to be collected once the 12-month data collection has been completed.

IPD Sharing Access Criteria

All Individualized Patient Data will be de-identifiable. The primary study PI will be the organizer of all data and then once put all together, the primary study PI will share the data with the additional co-investigators. No other identifying information will be provided as all patients will have a specific code (site # (1-4), sequence of consenting (1-7) and lettering of interval (A-preop, B-3months, C-6months or D-12months). All data will be kept in a password protected desktop used solely by the primary study PI in Bryan Heart Mechanical Circulatory Support office to which the data is protected through Bryan Heart's IT department policies.

IPD Sharing Supporting Information Type

  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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