NCT04893278

Brief Summary

The purpose of this study is to evaluate the use of virtual reality (VR) technology as adjunct to routine anesthesia care for patients undergoing electrophysiology (EP) procedures.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
7mo left

Started Jul 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Jul 2021Dec 2026

First Submitted

Initial submission to the registry

May 14, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 19, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

July 31, 2021

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

5.3 years

First QC Date

May 14, 2021

Last Update Submit

January 19, 2026

Conditions

AblationPVC - Premature Ventricular Complex

Keywords

virtual reality

Outcome Measures

Primary Outcomes (1)

  • Virtual reality as distractor

    Evaluate patients' experience and satisfaction with using virutal reality during electrophysiology procedures

    Up to 2hours

Secondary Outcomes (2)

  • Impact of virtual reality use on pharmacological therapy

    Up to 2 hours

  • Impact of virtual reality on electrophysilogy procedure

    Up to 2 hours

Study Arms (1)

Virtual reality

Other: Virtual reality

Interventions

Virtual realityOTHER

Use of Virtual reality goggles during procedure

Virtual reality

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects will be selected from patients undergoing procedures under monitored anesthesia care.

You may qualify if:

  • Age ≥ 18 years old.
  • Patients scheduled for electrophysiology procedure with MAC.
  • Subject willing to participate and able to provide informed consent.

You may not qualify if:

  • Age \< 18 years old.
  • History of motion sickness or blindness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

MeSH Terms

Conditions

Ventricular Premature Complexes

Condition Hierarchy (Ancestors)

Cardiac Complexes, PrematureArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Klaus Torp, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 14, 2021

First Posted

May 19, 2021

Study Start

July 31, 2021

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)