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

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

⁃ (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)

Locations
United States
Nebraska
Bryan Heart
RECRUITING
Lincoln
Wisconsin
Advocate Aurora Health
NOT_YET_RECRUITING
Milwaukee
Contact Information
Primary
Sarah E Schroeder, PhD, MSN, BSN, RN-Diploma
sarah.schroeder@bryanheart.com
402-481-8450
Backup
Kristin Sandau, PhD, RN
KSandau@umn.edu
612-625-0186
Time Frame
Start Date: 2025-08-17
Estimated Completion Date: 2026-12
Participants
Target number of participants: 10
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Bryan Heart
Collaborators: International Consortium of Circulatory Assist Clinicians, International Society for Heart and Lung Transplantation

This content was sourced from clinicaltrials.gov