Anxiety Reduction in TAVI Using Virtual Reality Trial

NCT ID: NCT05069987

Last Updated: 2022-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-16
• Study Completion Date: 2023-05-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VR-immersion

Group Type: EXPERIMENTAL

Virtual Reality Immersion

Intervention Type: 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.

Non-VR control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Reality Immersion

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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Nicolas van Mieghem

Prof. Dr. Nicolas Van Mieghem

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Erasmus University Medical Center

Rotterdam, South Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Nicolas Van Mieghem, MD, PhD

Role: CONTACT

n.vanmieghem@erasmusmc.nl

+31107035260

Facility Contacts

Nicolas Van Mieghem

Role: primary

n.vanmieghem@erasmusmc.nl

Other Identifiers

NL77298.078.21

Identifier Type: OTHER

Identifier Source: secondary_id

MEC-2021-0417

Identifier Type: -

Identifier Source: org_study_id