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| ID | Type | Description | Link |
|---|---|---|---|
| NL77298.078.21 | Other Identifier | Central Commissie Mensgebonden Onderzoek |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR-immersion | Experimental |
| |
| Non-VR control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality Immersion | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Anxiety | Procedural anxiety assessed on a visual analogue scale directly post-procedure. Range: 0 (no anxiety) to 10 (worst anxiety). | Immediately after the TAVR procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Anxiety | Difference between pre-procedural and post-procedural anxiety visual analogue scale scores | 1 day (From directly before the TAVR procedure until directly after the TAVR procedure) |
| Procedural Pain |
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported procedural Nausea and Vomiting | Patient reported nausea and vomiting during the procedure (yes/no) | Up to 1 day (Depending on procedure duration) |
| Admission time | Time leaving cathlab until discharge |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas Van Mieghem, MD, PhD | Contact | +31107035260 | n.vanmieghem@erasmusmc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus University Medical Center | Recruiting | Rotterdam | South Holland | 3015 GD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40393868 | Derived | 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. |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D063367 | Virtual Reality Exposure Therapy |
| ID | Term |
|---|---|
| D003887 | Desensitization, Psychologic |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Subjects will be randomly assigned, in a 1:1 ratio, to either procedural VR-immersion or non-VR control.
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Procedural pain assessed on a visual analogue scale directly post-procedure. Range: 0 (no pain) to 10 (worst pain).
| Immediately after the TAVR procedure |
| Procedural Use of Sedatives | Procedural sedative use and dosage. Amount of benzodiazepine used in milligrams | 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 | 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). | One day post procedure |
| Up to 7 days |
| D014694 |
| Ventricular Outflow Obstruction |
| D001523 | Mental Disorders |