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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety; Aortic Stenosis, Severe
• Intervention / Treatment: Other: Virtual Reality Immersion

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Zuid Holland
    • Rotterdam, Zuid Holland, Netherlands, 3015 GD
      • Recruiting
      • Erasmus University Medical Center
      • Contact: Nicolas Van Mieghem; Email: n.vanmieghem@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR-immersion	Other: 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.
No Intervention: Non-VR control

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	Up to 7 days

Collaborators and Investigators

• Sponsor: Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): May 31, 2023

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: TAVR; Immersive Virtual Reality; Procedural Anxiety
• Additional Relevant MeSH Terms: Mental Disorders; Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Anxiety Disorders; Aortic Valve Stenosis
• Other Study ID Numbers: MEC-2021-0417; NL77298.078.21 (Other Identifier: Central Commissie Mensgebonden Onderzoek)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No