NCT05552352 VRAP-Heart - Virtual Reality Assisted Patient Empowerment for Interventions in Structural Heart Disease
| NCT ID | NCT05552352 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Heinrich-Heine University, Duesseldorf |
| Condition | Severe Aortic Valve Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2022-10-05 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2022-10-05 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * High-grade aortic valve stenosis * Indication for elective transfemoral transcatheter aortic valve implantation under analgesia (TAVI) * Existing heart center decision * Age ≥ 18 years * Signed informed consent form Exclusion Criteria: * 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, glasses) together with the VR glasses in the event of defective vision, tested with the VR goggles fitted without using the VRAP-Heart software * Moderately severe or severe dementia syndrome noted in the medical history or identified during the informed consent discussion * Known seizure disorder (epilepsy) * Positive pregnancy test on inclusion and/or pregnancy is present * Court ordered placement in an institution * Any psychosocial condition that makes compliance with the protocol unlikely
Contact & Investigator
Christian Jung, Prof MD PhD
PRINCIPAL INVESTIGATOR
Heinrich-Heine University, Duesseldorf
Frequently Asked Questions
Who can join the NCT05552352 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Severe Aortic Valve Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05552352 currently recruiting?
Yes, NCT05552352 is actively recruiting participants. Contact the research team at christian.jung@med.uni-duesseldorf.de for enrollment information.
Where is the NCT05552352 trial being conducted?
This trial is being conducted at Düsseldorf, Germany, Cologne, Germany.
Who is sponsoring the NCT05552352 clinical trial?
NCT05552352 is sponsored by Heinrich-Heine University, Duesseldorf. The principal investigator is Christian Jung, Prof MD PhD at Heinrich-Heine University, Duesseldorf. The trial plans to enroll 300 participants.