Severe Aortic Valve StenosisVRAP-HeartNCT05552352
VRAP-Heart - Virtual Reality Assisted Patient Empowerment for Interventions in Structural Heart Disease
A study testing Virtual Reality assisted information in people with Severe Aortic Valve Stenosis, run by Heinrich-Heine University, Duesseldorf at 2 sites in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Aortic Valve Stenosis
- What is being tested?
- Virtual Reality assisted information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesGermany
- Study dates
- 5 Oct 2022to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Universitätsklinikum Köln, Klinik III für Innere Medizin, Herzzentrum, Kerpener Straße 62
Cologne, 50937
Matti Adam, PD Dr., +49 221 478-8777, matti.adam@uk-koeln.de
- Recruiting
Universitätsklinikum Düsseldorf, Klinik für Kardiologie, Pneumologie & Angiologie
Düsseldorf, North Rhine-Westphalia, 40225
Christian Jung, Prof. MD PhD, +4921181 ext. 18567, christian.jung@med.uni-duesseldorf.de
Raphael Bruno, MD, +4921181 ext. 18800, raphael.bruno@med.uni-duesseldorf.de
About this study
Official title: VRAP-Heart - Virtual Reality Assisted Patient Empowerment for Interventions in Structural Heart Disease - A Randomized-Controlled Multicenter Study
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.
Read the detailed description
This prospective, randomized-controlled multicenter study investigates whether VR-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. Disorientation, anxiety, and pain can lead to the development of delirium and, through complications, to prolonged hospital stays during elective procedures. Virtual reality can combine different learning modalities (auditory, visual, written, haptic) and improve patient understanding of the procedure through educational interventions. More detailed knowledge of the environment, the players, the procedure, and safety aspects will reduce anxiety and stress before and during the procedure and reduce complications during post-interventional care. As a result, length of stay should be reduced.
- Conditions
- Severe Aortic Valve Stenosis
- Being tested
- Virtual Reality assisted information
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality assisted informationOther
Patients in the intervention group receive a VR instructional application in the patient's room the day before TAVI implantation and in the operational suite during TAVI implantation the next day. In this application, the patient is guided through different VR parts that repeat the indication, the procedure, the localities and the post-interventional phase of the implantation with the corresponding safety instructions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Patients in the intervention arm receive on the day before the implantation of the artificial aortic valve, a virtual reality assisted information. On the day of the implantation the patients are informed about the process via virtual reality assisted information. Receives: Other: Virtual Reality assisted information |
| Control Arm | No intervention | Patients in the control arm receive no virtual reality assisted information. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay in days
Primary endpoint is the mean hospital stay in each group in days.
Measured: from start of hospitalizations until hospital leave up until day 360
Secondary outcomes (12)
Mental state on the day before the procedure as assessed by visual analog scale
Anxiety and psychological stress are common before elective procedures such as TAVI. Both are considered triggers and amplifiers of delirium. Patients are asked to quantify their anxiety before the procedure using a visual analog scale ranging from 1 to 10.
Measured: 1 day before procedure
Mental state on the day before the procedure as assessed by State-Trait-Anxiety-Inventory questionnaire
Anxiety and psychological stress are common before elective procedures such as TAVI. Both are considered triggers and amplifiers of delirium. Patients are asked to quantify their anxiety before the procedure using State-Trait-Anxiety-Inventory with minimum outcome 10 and maximum outcome 80. Lesser outcome means more anxiety.
Measured: 1 day before procedure
Mental state on the day before the procedure as assessed by Hospital Anxiety and Depression Scale German Version questionnaire
Anxiety and psychological stress are common before elective procedures such as TAVI. Both are considered triggers and amplifiers of delirium. Patients are asked to quantify their anxiety before the procedure using Hospital Anxiety and Depression Scale German Version questionnaire. Anxiety scale in the questionnaire has values from 0 to 21 and Depression scale has values from 0 to 21. Lesser values denote less anxiety or depression.
Measured: 1 day before procedure
Anxiety during the procedure as assessed by visual analog scale
Anxiety and psychological stress are common during elective procedures such as TAVI. Both are considered triggers and amplifiers of delirium. Patients are asked to quantify their anxiety before the procedure using a visual analog scale ranging from 1 to 10.
Measured: during procedure
Anxiety during the procedure as assessed by State-Trait-Anxiety-Inventory questionnaire
Anxiety and psychological stress are common during elective procedures such as TAVI. Both are considered triggers and amplifiers of delirium. Patients are asked to quantify their anxiety before the procedure using State-Trait-Anxiety-Inventory with minimum outcome 10 and maximum outcome 80. Lesser outcome means more anxiety.
Measured: during procedure
Pain during the procedure
Pain can occur despite analgesia during an elective procedure such as TAVI. Pain is considered a trigger and amplifier of delirium. Patients are asked to quantify their pain on a visual analog scale during the procedure (time point: procedure performed but still in the hybrid operating room). Here, 0 corresponds to no pain and 10 to the maximum imaginable pain.
Measured: during procedure
Anxiety/stress before, during, and after surgery (measured as serum cortisol)
Anxiety and psychological stress are common before and during elective procedures such as TAVI. Both are considered triggers and amplifiers of delirium. Patients will have routine blood samples taken before, during, and after the procedure. From these, the parameter cortisol in serum is additionally determined optionally in the context of this study. Serum cortisol is an established parameter to quantify anxiety and stress, especially intraindividually.
Measured: on the 1 day before, during and on day 1-3 after procedure
Anxiety / stress before, during and after the procedure (amylase and cortisol in saliva).
Patients will have saliva samples taken before, during and after the procedure. From these, the parameters cortisol and alpha-amylase are additionally determined on an optional basis within the scope of this study. Both parameters are considered established to quantify anxiety and stress especially intraindividually.
Measured: on the 1 day before, during and on day 1-3 after procedure
Knowledge test after informed consent
In order to test to what extent the addition of a combination of different learning modalities (acoustic, visual, written, haptic) implemented in virtual reality to the medico-legal informed consent is superior to the standard informed consent, a survey is conducted after the informed consent.
Measured: 1 day before procedure after informed consent
Major bleeding and minor bleeding during hospitalization.
Bleeding is a typical complication after cardio-vascular interventional procedures. Unawareness, disorientation, falls, and delirium favor the occurrence of bleeding. After hospital discharge, the occurrence of bleeding is recorded according to Valve Academic Research Consortium-2 consensus document (VARC), which is based on the bleeding academic research consortium (BARC) classification.
Measured: at hospital leave up to 360 days after procedure
Survival / rehospitalization at 6 and 12 months
After 6 and 12 months patients are contacted and information is gathered about survival of the patients and possible rehospitalization events.
Measured: after 6 and 12 months after hospital leave
Maximum length of hospital stay, in days
In addition to the mean hospital stay in days, a maximum hospital stay is also calculated.
Measured: at hospital leave up to 360 days after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start5 Oct 2022
- Primary completion31 Aug 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-armed, randomized with controlled parallel groups.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Sponsor
- Investigators
- Christian Jung, Prof MD PhD, Principal investigator, Heinrich-Heine University, Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552352
- Sponsor's protocol ID
- VRAP-Heart
- Acronym
- VRAP-Heart
- Status last verified
- Aug 2025
- First submitted
- 12 Sep 2022
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VRAP-Heart - Virtual Reality Assisted Patient Empowerment for Interventions in Structural Heart Disease - A Randomized-Controlled Multicenter Study
- ClinicalTrials.gov ID
- NCT05552352
- Acronym / sponsor ID
- VRAP-Heart / VRAP-Heart
- Conditions
- Severe Aortic Valve Stenosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This prospective, randomized-controlled multicenter study investigates whether VR-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. Disorientation, anxiety, and pain can lead to the development of delirium and, through complications, to prolonged hospital stays during elective procedures. Virtual reality can combine different learning modalities (auditory, visual, written, haptic) and improve patient understanding of the procedure through educational interventions. More detailed knowledge of the environment, the players, the procedure, and safety aspects will reduce anxiety and stress before and during the procedure and reduce complications during post-interventional care. As a result, length of stay should be reduced.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-armed, randomized with controlled parallel groups.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Virtual Reality assisted informationPatients in the intervention arm receive on the day before the implantation of the artificial aortic valve, a virtual reality assisted information. On the day of the implantation the patients are informed about the process via virtual reality assisted information. |
| Control Arm | No intervention | –Patients in the control arm receive no virtual reality assisted information. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality assisted informationPatients in the intervention group receive a VR instructional application in the patient's room the day before TAVI implantation and in the operational suite during TAVI implantation the next day. In this application, the patient is guided through different VR parts that repeat the indication, the procedure, the localities and the post-interventional phase of the implantation with the corresponding safety instructions. | Other | Intervention Arm |
Primary outcome
Length of hospital stay in days
Time frame: from start of hospitalizations until hospital leave up until day 360
Primary endpoint is the mean hospital stay in each group in days.
12 secondary outcomes
Mental state on the day before the procedure as assessed by visual analog scale
Time frame: 1 day before procedure
Mental state on the day before the procedure as assessed by State-Trait-Anxiety-Inventory questionnaire
Time frame: 1 day before procedure
Mental state on the day before the procedure as assessed by Hospital Anxiety and Depression Scale German Version questionnaire
Time frame: 1 day before procedure
Anxiety during the procedure as assessed by visual analog scale
Time frame: during procedure
Anxiety during the procedure as assessed by State-Trait-Anxiety-Inventory questionnaire
Time frame: during procedure
Pain during the procedure
Time frame: during procedure
Anxiety/stress before, during, and after surgery (measured as serum cortisol)
Time frame: on the 1 day before, during and on day 1-3 after procedure
Anxiety / stress before, during and after the procedure (amylase and cortisol in saliva).
Time frame: on the 1 day before, during and on day 1-3 after procedure
Knowledge test after informed consent
Time frame: 1 day before procedure after informed consent
Major bleeding and minor bleeding during hospitalization.
Time frame: at hospital leave up to 360 days after procedure
Survival / rehospitalization at 6 and 12 months
Time frame: after 6 and 12 months after hospital leave
Maximum length of hospital stay, in days
Time frame: at hospital leave up to 360 days after procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christian Jung, Prof MD PhD principal investigator
Heinrich-Heine University, Duesseldorf
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality assisted information in people with Severe Aortic Valve Stenosis, run by Heinrich-Heine University, Duesseldorf at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian Jung, Prof MD PhD (+49 211 81 ext. 18567, christian.jung@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay in days (time frame: from start of hospitalizations until hospital leave up until day 360). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.