Anxiety Reduction in TAVI Using Virtual Reality Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Anxiety Reduction in TAVI Using Virtual Reality Trial

Conditions
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Aortic Stenosis, Severe, Anxiety

Intervention / Treatment
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* Other: Virtual Reality Immersion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VR-immersion<br> | Other: Virtual Reality Immersion<br>* 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.<br>|
| No Intervention: Non-VR control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immersive Virtual Reality, Procedural Anxiety, TAVR