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

Launched by HEINRICH-HEINE UNIVERSITY, DUESSELDORF · Sep 22, 2022

Keywords

ClinConnect Summary

The VRAP-Heart clinical trial is studying how using virtual reality (VR) can help patients better understand their treatment for severe aortic valve stenosis, a condition where the heart's aortic valve doesn't open properly. This trial is for patients who are scheduled to undergo a specific procedure called a transfemoral transcatheter aortic valve implantation (TAVI), which replaces the damaged valve without major surgery. The researchers want to see if VR can improve patient education and comfort, potentially leading to fewer complications and shorter hospital stays.

To be eligible for the trial, participants should be at least 18 years old, have been diagnosed with severe aortic valve stenosis, and have a doctor’s recommendation for the TAVI procedure. Participants will learn about their treatment through virtual reality, which may make the experience more engaging and easier to understand. It’s important to know that some individuals, such as those who might have severe hearing or vision issues, advanced dementia, or are currently pregnant, cannot participate. The trial is currently recruiting patients, and everyone involved will need to provide informed consent, meaning they agree to participate after understanding what the study involves.

Gender

ALL

Eligibility criteria

• 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
• • Severe hearing or vision impairment
• • Advanced dementia syndrome
• • 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