NCT06823583

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
7mo left

Started Aug 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Aug 2025Dec 2026

First Submitted

Initial submission to the registry

January 12, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 12, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

August 17, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

1.3 years

First QC Date

January 12, 2025

Last Update Submit

September 15, 2025

Conditions

Ventricular Assist DeviceAdvanced Heart FailureAnticipatory Guidance

Keywords

expectationsVADAdvanced Heart FailureAnticipatory Guidancequality of life

Outcome Measures

Primary Outcomes (1)

  • 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

    First two weeks of study initiation.

Other Outcomes (6)

  • Distribution of the Ventricular Assist Device Anticipatory Guidance Tool (VAD AG Tool) v5.0

    12 months

  • Postoperative patient perceptions of Ventricular Assist Device Anticipatory Guidance Tool (VAD AG Tool) v5.0

    12 months

  • Complete post-operative Quality of Life with a Left Ventricular Assist Device (QoLVAD)

    12 months

  • +3 more other outcomes

Study Arms (2)

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.

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • Not scheduled for VAD surgery
  • Non English speaking
  • \<19 yrs of age (Not a VAD Clinician for the clinician evaluation process)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bryan Heart

Lincoln, Nebraska, 68506, United States

RECRUITING

Advocate Aurora Health

Milwaukee, Wisconsin, 53215, United States

NOT YET RECRUITING

Related Publications (11)

  • Waldenburger N, Steinecke M, Peters L, Junemann F, Bara C, Zimmermann T. Depression, anxiety, fear of progression, and emotional arousal in couples after left ventricular assist device implantation. ESC Heart Fail. 2020 Oct;7(5):3022-3028. doi: 10.1002/ehf2.12927. Epub 2020 Jul 28.

    PMID: 32725771BACKGROUND

  • Highs and Lows of Life with a Left Ventricular Assist Device: Multi-Dimensional Perspectives Schroeder, S.E. et al. The Journal of Heart and Lung Transplantation, Volume 43, Issue 4, S606

    BACKGROUND

  • Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013 Aug 20;13:104. doi: 10.1186/1471-2288-13-104.

    PMID: 23961782BACKGROUND

  • Longitudinal Quality of Life Assessment Following Ventricular Assist Device Therapy: A Pilot Study Using the QOLVAD Questionnaire Schroeder, S.E. et al. The Journal of Heart and Lung Transplantation, Volume 39, Issue 4, S91

    BACKGROUND

  • Sandau KE, Lee CS, Faulkner KM, Pozehl B, Eckman P, Garberich R, Weaver CE, Joseph SM, Hall S, Carey SA, Chaudhry SP, Schroeder SE, Hoffman RO 3rd, Feldman D, Birati EY, Soni M, Marble JF, Jurgens CY, Hoglund B, Cowger JA. Health-Related Quality of Life in Patients With a Left Ventricular Assist Device (QOLVAD) Questionnaire: Initial Psychometrics of a New Instrument. J Cardiovasc Nurs. 2021 Mar-Apr 01;36(2):172-184. doi: 10.1097/JCN.0000000000000774.

    PMID: 33306621BACKGROUND

  • Birriel B, Alonso W, Kitko LA, Hupcey JE. Family caregiver-reported outcomes regarding decision-making for left ventricular assist device implantation. Heart Lung. 2019 Jul-Aug;48(4):308-312. doi: 10.1016/j.hrtlng.2019.03.002. Epub 2019 Apr 10.

    PMID: 30981423BACKGROUND

  • Kitko LA, Hupcey JE, Birriel B, Alonso W. Patients' decision making process and expectations of a left ventricular assist device pre and post implantation. Heart Lung. 2016 Mar-Apr;45(2):95-9. doi: 10.1016/j.hrtlng.2015.12.003. Epub 2015 Dec 29.

    PMID: 26742707BACKGROUND

  • McIlvennan CK, Magid KH, Ambardekar AV, Thompson JS, Matlock DD, Allen LA. Clinical outcomes after continuous-flow left ventricular assist device: a systematic review. Circ Heart Fail. 2014 Nov;7(6):1003-13. doi: 10.1161/CIRCHEARTFAILURE.114.001391. Epub 2014 Oct 7.

    PMID: 25294625BACKGROUND

  • Sandau KE, Hoglund BA, Weaver CE, Boisjolie C, Feldman D. A conceptual definition of quality of life with a left ventricular assist device: results from a qualitative study. Heart Lung. 2014 Jan-Feb;43(1):32-40. doi: 10.1016/j.hrtlng.2013.09.004. Epub 2013 Oct 2.

    PMID: 24239297BACKGROUND

  • Mehra MR, Goldstein DJ, Cleveland JC, Cowger JA, Hall S, Salerno CT, Naka Y, Horstmanshof D, Chuang J, Wang A, Uriel N. Five-Year Outcomes in Patients With Fully Magnetically Levitated vs Axial-Flow Left Ventricular Assist Devices in the MOMENTUM 3 Randomized Trial. JAMA. 2022 Sep 27;328(12):1233-1242. doi: 10.1001/jama.2022.16197.

    PMID: 36074476BACKGROUND

  • Bytyci I, Bajraktari G. Mortality in heart failure patients. Anatol J Cardiol. 2015 Jan;15(1):63-8. doi: 10.5152/akd.2014.5731. Epub 2014 Aug 19.

    PMID: 25550250BACKGROUND

Study Officials

  • Mathue Baker, MD

    Bryan Heart

    STUDY CHAIR

Central Study Contacts

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

CONTACT

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

Kristin Sandau, PhD, RN

CONTACT

612-625-0186KSandau@umn.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Left Ventricular Assist Device Nurse Practitioner and Program Manager

Study Record Dates

First Submitted

January 12, 2025

First Posted

February 12, 2025

Study Start

August 17, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
SAP
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.
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.

Locations

US(2)