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

Erasmus University

Status: Enrolling

Conditions: Aortic Stenosis, Severe; Anxiety

Treatments: Other: Virtual Reality Immersion

Study type: Interventional

Funder types: Other

Identifiers

NCT05069987

NL77298.078.21 (Other Identifier)

MEC-2021-0417

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

VR-immersion

Experimental group

Treatment:

Other: Virtual Reality Immersion

Non-VR control

No Intervention group