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Clinical Trials in Germany / NCT05552352
Recruiting Not applicable

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

NCT05552352 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2022-10-05
Last updated
2025-08-28

Condition(s) studied

Severe Aortic Valve Stenosis

Investigational drug(s) / intervention(s)

Virtual Reality assisted information

Virtual Reality assisted information: 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Universitätsklinikum Düsseldorf, Klinik für Kardiologie, Pneumologie & Angiologie Düsseldorf North Rhine-Westphalia Recruiting
Universitätsklinikum Köln, Klinik III für Innere Medizin, Herzzentrum, Kerpener Straße 62 Cologne Germany Recruiting

More Heinrich-Heine University, Duesseldorf trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05552352 on ClinicalTrials.gov ↗ ← All trials in Germany