VRAP-Heart - Virtual Reality Assisted Patient Empowerment for Interventions in Structural Heart Disease
VRAP-Heart - Virtual Reality Assisted Patient Empowerment for Interventions in Structural Heart Disease - A Randomized-Controlled Multicenter Study
Heinrich-Heine University, Duesseldorf
300 participants
Oct 5, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria9
- 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
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Interventions
Patients in the intervention group receive a VR instructional application in the patient's room the day before TAVI implantation and in the operational suite during TAVI implantation the next day. In this application, the patient is guided through different VR parts that repeat the indication, the procedure, the localities and the post-interventional phase of the implantation with the corresponding safety instructions.
Locations(2)
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NCT05552352