Anxiety Reduction in TAVI Using Virtual Reality Trial

NCT05069987 | Unknown

• 2 other identifiers: MEC-2021-0417NL77298.078.21
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Stenosis, Severe; Anxiety

Keywords

Immersive Virtual Reality; Procedural Anxiety; TAVR

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change of Anxiety

  1 day (From directly before the TAVR procedure until directly after the TAVR procedure)

• Procedural Pain

  Immediately after the TAVR procedure

• Procedural Use of Sedatives

  Up to 1 day (Depending on procedure duration)

• Procedural Use of Analgesics

  Up to 1 day (Depending on procedure duration)

• Patient Procedural Satisfaction

  One day post procedure

Other Outcomes (2)

• Patient reported procedural Nausea and Vomiting

  Up to 1 day (Depending on procedure duration)

• Admission time

  Up to 7 days

Study Arms (2)

VR-immersion

EXPERIMENTAL

Other: Virtual Reality Immersion

Non-VR control

NO INTERVENTION

Interventions

Virtual Reality Immersion 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.

VR-immersion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus University Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis; Anxiety Disorders

Interventions

Virtual Reality Exposure Therapy

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Nicolas Van Mieghem, MD, PhD

CONTACT

+31107035260; n.vanmieghem@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Nicolas Van Mieghem

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

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 6, 2021
• Study Start: September 16, 2021
• Primary Completion: December 31, 2022
• Study Completion: May 31, 2023
• Last Updated: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

NL (1)