Actively Recruiting
VRAP-Heart - Virtual Reality Assisted Patient Empowerment for Interventions in Structural Heart Disease - A Randomized-Controlled Multicenter Study
Led by Heinrich-Heine University, Duesseldorf · Updated on 2025-08-28
300
Participants Needed
2
Research Sites
25 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
Researchers are evaluating the use of virtual reality (VR) to assist patient education for individuals undergoing transfemoral transcatheter aortic valve implantation (TAVI) to treat severe aortic valve stenosis. This prospective, randomized-controlled multicenter study aims to see if VR can improve patients' understanding and orientation about the procedure, reduce anxiety and disorientation, lower postinterventional complications, and shorten hospital stays. The study addresses how combining auditory, visual, written, and haptic learning through VR may enhance patient knowledge and safety. Participants are randomly assigned to one of two groups. The intervention group receives VR-assisted information the day before and on the day of their TAVI procedure, which guides them through the indication, procedure, environment, and safety instructions. The control group receives standard care without VR assistance. This approach is designed to reduce stress and improve patient orientation before and during the procedure. During the study, participants will be assessed on their mental state using questionnaires and scales before and during the procedure. Researchers will track anxiety, pain, stress markers like cortisol, knowledge about the procedure, bleeding events, survival, rehospitalization, and length of hospital stay up to 360 days after treatment. The total study duration includes hospital stay and follow-up assessments at 6 and 12 months to evaluate long-term outcomes and safety.
CONDITIONS
Brief 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 (TAVI) under analgesia
- Existing heart center decision
- 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 trial and follow VR instructions
- Severe hearing impairment preventing understanding of VR audio
- Severe visual impairment not correctable with glasses or contact lenses when using VR goggles
- Moderately severe or severe dementia
- Known seizure disorder (epilepsy)
- Positive pregnancy test or pregnancy present
- Court-ordered placement in an institution
- Psychosocial conditions likely to prevent protocol compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 days
Participants undergo transfemoral transcatheter aortic valve implantation (TAVI). Those in the intervention group receive virtual reality assisted information the day before and during the procedure to improve understanding and reduce anxiety.
1 visit the day before the procedure and 1 visit on the day of the procedure
Duration - Up to 360 days after hospital discharge
Participants are monitored for complications, anxiety, pain, and length of hospital stay following the procedure.
Follow-up visits as per hospital discharge and up to 1 year post-procedure
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
R
Raphael Bruno, MD
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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