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New treatment option for Severe Aortic Valve Stenosis
Official title VRAP-Heart - Virtual Reality Assisted Patient Empowerment for Interventions in Structural Heart Disease
ClinicalTrials.gov ID: NCT05552352
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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 likely can't join 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...
- Severe hearing impairment, preventing the patient from understanding the sound of the VR goggles, tested with the VR goggles fitted without using the...
- Severe visual impairment that prevents viewing of the VR modules if it is not possible to use existing visual corrections (contact lenses, glasses)...
- Moderately severe or severe dementia syndrome noted in the medical history or identified during the informed consent discussion
- Known seizure disorder (epilepsy)
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Düsseldorf, North Rhine-Westphalia, Germany
- Cologne, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Düsseldorf, North Rhine-Westphalia, Germany; Cologne, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.