Actively Recruiting
VRAP-Heart - Virtual Reality Assisted Patient Empowerment for Interventions in Structural Heart Disease
Led by Heinrich-Heine University, Duesseldorf · Updated on 2025-08-28
300
Participants Needed
2
Research Sites
229 weeks
Total Duration
On this page
Sponsors
H
Heinrich-Heine University, Duesseldorf
Lead Sponsor
E
Edwards Lifesciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
VRAP-Heart - Virtual Reality Assisted Patient Empowerment for Interventions in Structural Heart Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- High-grade aortic valve stenosis
- Indication for elective transfemoral transcatheter aortic valve implantation under analgesia (TAVI)
- Existing heart center decision for treatment
- Age 18 years or older
- Signed informed consent form
You will not qualify if you...
- Planned surgery under general anesthesia
- Insufficient language proficiency to understand the study and VR application
- Severe hearing impairment preventing understanding of VR sounds
- Severe visual impairment preventing viewing of VR modules without correction
- Moderately severe or severe dementia syndrome
- Known epilepsy or seizure disorder
- Positive pregnancy test or current pregnancy
- Court ordered institutional placement
- Psychosocial conditions likely to prevent protocol compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Universitätsklinikum Düsseldorf, Klinik für Kardiologie, Pneumologie & Angiologie
Düsseldorf, North Rhine-Westphalia, Germany, 40225
Actively Recruiting
2
Universitätsklinikum Köln, Klinik III für Innere Medizin, Herzzentrum, Kerpener Straße 62
Cologne, Germany, 50937
Actively Recruiting
Research Team
C
Christian Jung, Prof MD PhD
CONTACT
R
Raphael Bruno, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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