Virtual-reality education for patients undergoing transfemoral TAVI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Registry for patients with severe aortic valve stenosis undergoing TAVR with Myval valve

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.