Virtual-reality education for patients undergoing transfemoral TAVI
VRAP-Heart - Virtual Reality Assisted Patient Empowerment for Interventions in Structural Heart Disease - A Randomized-Controlled Multicenter Study
This trial will see if virtual-reality patient education helps adults with severe aortic stenosis who are having elective transfemoral TAVI understand the procedure better and have fewer postprocedural complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Heinrich-Heine University, Duesseldorf Academic / other |
| Locations | 2 sites (Düsseldorf, North Rhine-Westphalia and 1 other locations) |
| Trial ID | NCT05552352 on ClinicalTrials.gov |
What this trial studies
This prospective, randomized-controlled multicenter trial will randomize adults scheduled for elective transfemoral TAVI to receive virtual-reality (VR)–assisted education versus standard information. The VR program combines auditory, visual, written, and haptic modules to familiarize patients with the procedure, the care environment, and safety aspects. Investigators hypothesize that improved understanding and simulated orientation will reduce pre- and peri-procedural anxiety, disorientation, pain, and the risk of delirium, thereby lowering postprocedural complications. The primary outcome is expected to be length of hospital stay, with secondary outcomes including patient knowledge, anxiety scores, delirium incidence, and complication rates.
Who should consider this trial
Good fit: Adults (≥18) with high-grade aortic stenosis scheduled for elective transfemoral TAVI under conscious analgesia who can provide informed consent and use the VR equipment are ideal candidates.
Not a fit: Patients planned for general anesthesia, with severe hearing or vision impairment that prevents VR use, significant dementia, or insufficient language skills to follow the VR modules are unlikely to benefit.
Why it matters
Potential benefit: If successful, patients could experience less anxiety and fewer complications after transfemoral TAVI, leading to shorter hospital stays.
How similar studies have performed: Other surgical and procedural settings have shown that VR education can reduce preprocedural anxiety and improve patient knowledge, but evidence specific to TAVI patients is limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Düsseldorf, North Rhine-Westphalia and 1 other locations
- Universitätsklinikum Düsseldorf, Klinik für Kardiologie, Pneumologie & Angiologie — Düsseldorf, North Rhine-Westphalia, Germany (Recruiting)
- Universitätsklinikum Köln, Klinik III für Innere Medizin, Herzzentrum, Kerpener Straße 62 — Cologne, Germany (Recruiting)
Study contacts
- Principal investigator: Christian Jung, Prof MD PhD — Heinrich-Heine University, Duesseldorf
- Study coordinator: Christian Jung, Prof MD PhD
- Email: christian.jung@med.uni-duesseldorf.de
- Phone: +49 211 81
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.