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VRAP-Heart - Virtual Reality Assisted Patient Empowerment for Interventions in Structural Heart Disease

Study acronym: VRAP-Heart
StatusRecruiting
PhaseNot applicable
Started2022-10-05
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 28, 2025 (before its estimated August 31, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-08-22
Study Status, Eligibility, Contacts/Locations v2
Primary completion date2023-06-30→2026-08-31
Completion date2024-05-31→2027-02-28
Study sites1→2
Eligibility criteria+672 characters
[...] a: Surgery planned under general anesthesia Language barrier, defined as insufficient language proficiency at the discretion of the investigator to understand the purpose of the trial and follow the VR application. Severe hearing impairment, preventing the patient from understanding the sound of the VR goggles, tested with the VR goggles fitted without using the VRAP-Heart software Severe visual impairment that prevents viewing of the VR modules if it is not possible to use existing visual corrections (contact lenses, glasse [...] or vision impairment Advancedsevere dementia syndrome noted in the med [...] [...]
2022-12-22
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-09→confirmed 2022-10-05
Study sites0→1
2022-09-22
Original filing
This prospective, randomized-controlled multicenter study investigates whether virtual reality-assisted patient education in patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) can improve patient understanding and simulative orientation, thereby reducing postinterventional complications, resulting in significantly shorter length of stay.
Trial Details
NCT Number NCT05552352
Lead Sponsor Heinrich-Heine University, Duesseldorf
Collaborators: Edwards Lifesciences
Conditions Severe Aortic Valve Stenosis
Enrollment 300 participants
Start Date 2022-10-05
Primary Completion 2026-08-31 (estimated)
Study Completion 2027-02-28 (estimated)
Updated on ClinicalTrials.gov 2025-08-28