Anxiety Reduction in TAVI Using Virtual Reality Trial (ART-VR)

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.

Subjects will be randomly assigned, in a 1:1 ratio, to either procedural VR-immersion or non-VR control.

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.

Procedural anxiety assessed on a visual analogue scale directly post-procedure. Range: 0 (no anxiety) to 10 (worst anxiety).

Procedural pain assessed on a visual analogue scale directly post-procedure. Range: 0 (no pain) to 10 (worst pain).

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).

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)