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Anxiety Reduction in TAVI Using Virtual Reality Trial

NCT05069987 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2022-07-27

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-16
Primary Completion
2022-12-31
Completion
2023-05-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05069987 on ClinicalTrials.gov