Aortic Stenosis, SevereART-VRNCT05069987
Anxiety Reduction in TAVI Using Virtual Reality Trial
A study testing Virtual Reality Immersion in people with Aortic Stenosis, Severe and Anxiety, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
The ART-VR Trial is an international multi-center, open label, randomized controlled trial evaluating the effect of an immersive VR environment on procedural anxiety in patients undergoing transfemoral aortic valve replacement (TAVR) under local anaesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, Severe, Anxiety
- What is being tested?
- Virtual Reality Immersion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Sep 2021to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age ≥ 18 years
- Symptomatic severe aortic stenosis
- Indication for transfemoral TAVI under local anaesthesia per local heart team consensus
- Patient is able to understand and sign written informed consent
- Patient speaks Dutch, German or English
Who cannot join
- Need for emergent TAVI
- Need for planned concomitant cardiac intervention during index procedure
- History of TAVI under local anesthesia/conscious sedation
- Chronic use of benzodiapines, opioids, pregabalin or antidepressants
- History of opioid use (within 8-30 days prior to randomization)
- Claustrophobia
Show all 10Show fewer
- Any psychiatric illness diagnosed by a psychiatrist or psychologist
- Blindness or severe visual impairment despite visual aid (glasses, contact lenses)
- Epilepsy
- Extensive cognitive impairment (MMSE <21 or as diagnosed by geriatrician)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus University Medical Center
Rotterdam, South Holland, 3015 GD
Nicolas Van Mieghem, n.vanmieghem@erasmusmc.nl
About this study
The ART-VR Trial is an international multi-center, open label, randomized controlled trial evaluating the effect of an immersive VR environment on procedural anxiety in patients undergoing transfemoral aortic valve replacement (TAVR) under local anaesthesia.
Read the detailed description
Virtual reality (VR) allows patients to be fully immerged in an engaging, interactive 3D environment. Its applications are broad and include treatment of phobias, stress-disorders, pain reduction. Recently, VR has been adopted in various medical procedures to reduce pre- and per-procedural anxiety. In TAVR, per-procedural VR immersion could potentially reduce patient anxiety leading to increased overall patient satisfaction. However, contemporary large scale, randomized evidence on VR application in TAVR is lacking.
The objective of this trial is to evaluate the effect of an immersive VR environment on procedural anxiety in patients undergoing TAVR under local anaesthesia in a randomized controlled setting. A total of 150 patients with severe aortic stenosis (AS) who undergo transfemoral TAVR under local aneasthesia will be included. The main study endpoint is procedural anxiety assessed on a visual analogue scale (VAS) directly post-procedure.
- Conditions
- Aortic Stenosis, Severe, Anxiety
- Being tested
- Virtual Reality Immersion
- Keywords
- Immersive Virtual Reality, Procedural Anxiety, TAVR
- Medical subject headings
- Aortic Valve Stenosis, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality ImmersionOther
An immersive virtual reality experience will be generated by a head mounted device which shows the user pre-recorded videos (SynVR Relax \& Distract, SyncVR Medical BV, Utrecht, The Netherlands). These videos are recorded in 360 degree views and matched with the users' viewing direction by the head mounted device matches. The user will not be able to see its in vivo surroundings (i.e. the Cathlab) and will be focused on the digital content. The VR immersion will be put into place throughout the entire TAVR procedure starting before femoral access obtainment and ending after access closure.
| Study group | Role | What they receive |
|---|---|---|
| VR-immersion | Experimental | Not described Receives: Other: Virtual Reality Immersion |
| Non-VR control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Anxiety
Procedural anxiety assessed on a visual analogue scale directly post-procedure. Range: 0 (no anxiety) to 10 (worst anxiety).
Measured: Immediately after the TAVR procedure
Secondary outcomes (5)
Change of Anxiety
Difference between pre-procedural and post-procedural anxiety visual analogue scale scores
Measured: 1 day (From directly before the TAVR procedure until directly after the TAVR procedure)
Procedural Pain
Procedural pain assessed on a visual analogue scale directly post-procedure. Range: 0 (no pain) to 10 (worst pain).
Measured: Immediately after the TAVR procedure
Procedural Use of Sedatives
Procedural sedative use and dosage. Amount of benzodiazepine used in milligrams
Measured: Up to 1 day (Depending on procedure duration)
Procedural Use of Analgesics
Procedural analgesic use and dosage. Amount of Lidocaine (or equivalent) used in milligrams
Measured: Up to 1 day (Depending on procedure duration)
Patient Procedural Satisfaction
Procedural satisfaction assessed after 24hrs using for procedures under regional anaesthesia. Score assessed on a visual analogue scale. Range: 0 (not at all satisfied) to 10 (very satisfied).
Measured: One day post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start16 Sep 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Stenosis, SevereStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomly assigned, in a 1:1 ratio, to either procedural VR-immersion or non-VR control.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas van Mieghem, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069987
- Sponsor's protocol ID
- MEC-2021-0417
- Other IDs
- NL77298.078.21
- Acronym
- ART-VR
- Status last verified
- Jul 2022
- First submitted
- 20 Sep 2021
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Chatterjee S, Ooms J, de Ronde M, van Gorsel S, Mattace-Raso AM, Goudzwaard J, Mattace-Raso F, Kardys I, Nuis RJ, Daemen J, Van Mieghem N. Anxiety during transcatheter aortic valve replacement under local anesthesia - the ART-VR trial. Cardiovasc Revasc Med. 2025 Oct;79:71-77. doi: 10.1016/j.carrev.2025.05.015. Epub 2025 May 15.
PubMed 40393868
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiety Reduction in TAVI Using Virtual Reality Trial
- ClinicalTrials.gov ID
- NCT05069987
- Acronym / sponsor ID
- ART-VR / MEC-2021-0417
- Conditions
- Aortic Stenosis, Severe, Anxiety
- Keywords
- Immersive Virtual Reality, Procedural Anxiety, TAVR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 6 Oct 2021 (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.
The ART-VR Trial is an international multi-center, open label, randomized controlled trial evaluating the effect of an immersive VR environment on procedural anxiety in patients undergoing transfemoral aortic valve replacement (TAVR) under local anaesthesia.
Detailed description
Virtual reality (VR) allows patients to be fully immerged in an engaging, interactive 3D environment. Its applications are broad and include treatment of phobias, stress-disorders, pain reduction. Recently, VR has been adopted in various medical procedures to reduce pre- and per-procedural anxiety. In TAVR, per-procedural VR immersion could potentially reduce patient anxiety leading to increased overall patient satisfaction. However, contemporary large scale, randomized evidence on VR application in TAVR is lacking.
The objective of this trial is to evaluate the effect of an immersive VR environment on procedural anxiety in patients undergoing TAVR under local anaesthesia in a randomized controlled setting. A total of 150 patients with severe aortic stenosis (AS) who undergo transfemoral TAVR under local aneasthesia will be included. The main study endpoint is procedural anxiety assessed on a visual analogue scale (VAS) directly post-procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be randomly assigned, in a 1:1 ratio, to either procedural VR-immersion or non-VR control.
| Arm | Type | Receives |
|---|---|---|
| VR-immersion | Experimental | Other: Virtual Reality Immersion |
| Non-VR control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Symptomatic severe aortic stenosis
- Indication for transfemoral TAVI under local anaesthesia per local heart team consensus
- Patient is able to understand and sign written informed consent
- Patient speaks Dutch, German or English
Key exclusion criteria (10 listed)
- Need for emergent TAVI
- Need for planned concomitant cardiac intervention during index procedure
- History of TAVI under local anesthesia/conscious sedation
- Chronic use of benzodiapines, opioids, pregabalin or antidepressants
- History of opioid use (within 8-30 days prior to randomization)
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 ImmersionAn immersive virtual reality experience will be generated by a head mounted device which shows the user pre-recorded videos (SynVR Relax \& Distract, SyncVR Medical BV, Utrecht, The Netherlands). These videos are recorded in 360 degree views and matched with the users' viewing direction by the head mounted device matches. The user will not be able to see its in vivo surroundings (i.e. the Cathlab) and will be focused on the digital content. The VR immersion will be put into place throughout the entire TAVR procedure starting before femoral access obtainment and ending after access closure. | Other | VR-immersion |
Primary outcome
Procedural Anxiety
Time frame: Immediately after the TAVR procedure
Procedural anxiety assessed on a visual analogue scale directly post-procedure. Range: 0 (no anxiety) to 10 (worst anxiety).
5 secondary outcomes
Change of Anxiety
Time frame: 1 day (From directly before the TAVR procedure until directly after the TAVR procedure)
Procedural Pain
Time frame: Immediately after the TAVR procedure
Procedural Use of Sedatives
Time frame: Up to 1 day (Depending on procedure duration)
Procedural Use of Analgesics
Time frame: Up to 1 day (Depending on procedure duration)
Patient Procedural Satisfaction
Time frame: One day post procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Derived from this study: PubMed 40393868Chatterjee S, Ooms J, de Ronde M, van Gorsel S, Mattace-Raso AM, Goudzwaard J, Mattace-Raso F, Kardys I, Nuis RJ, Daemen J, Van Mieghem N. Anxiety during transcatheter aortic valve replacement under local anesthesia - the ART-VR trial. Cardiovasc Revasc Med. 2025 Oct;79:71-77. doi: 10.1016/j.carrev.2025.05.015. Epub 2025 May 15.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Immersion in people with Aortic Stenosis, Severe and Anxiety, run by Erasmus Medical Center at 1 site in Netherlands.
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 10 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: status not confirmed, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Van Mieghem, MD, PhD (+31107035260, n.vanmieghem@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural Anxiety (time frame: Immediately after the TAVR procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05069987, which also lists 1 linked publication.
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 27 Jul 2022.