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

Recruiting now · Not applicable

Conditions studied: Severe Aortic Valve Stenosis

In brief

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.

Key facts

Study ID

NCT05552352

Run by

Heinrich-Heine University, Duesseldorf

People needed

300

Starts

2022-10-05

Expected to finish

2027-02-28

Last updated by the study team

2025-08-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Universitätsklinikum Düsseldorf, Klinik für Kardiologie, Pneumologie & Angiologie — Düsseldorf, North Rhine-Westphalia, Germany (enrolling)
• Universitätsklinikum Köln, Klinik III für Innere Medizin, Herzzentrum, Kerpener Straße 62 — Cologne, Germany (enrolling)

Full record on ClinicalTrials.gov

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