Virtual Reality in Electrophysiology Laboratory (EP) | NCT04893278

Studies
Virtual Reality in Electrophysiology Laboratory (EP)

NCT04893278

Sponsor

Mayo Clinic

Status

Enrolling by invitation

Last Update Posted

Jan 21, 2026Actual

Enrollment

10Estimated

Phase

Not provided

Conditions

PVC - Premature Ventricular Complex
Ablation

Interventions

Virtual reality

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 31, 2021Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

May 14, 2021

First Submission Date that Met QC Criteria

May 14, 2021

First Posted Date

May 19, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 19, 2026

Last Update Posted Date

Jan 21, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Virtual reality			Other: Virtual reality

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Virtual reality	Other	Use of Virtual reality goggles during procedure	Virtual reality

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Virtual reality as distractor	Evaluate patients' experience and satisfaction with using virutal reality during electrophysiology procedures	Up to 2hours

Secondary Outcomes

Measure	Description	Time Frame
Impact of virtual reality use on pharmacological therapy	Evalute the amount of medications use during the procedure	Up to 2 hours
Impact of virtual reality on electrophysilogy procedure	Evaluate success rate of completing ablation while patient is utilizing virtual reality

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Klaus Torp, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Florida		Jacksonville	Florida	32224	United States

Label	URL
Mayo Clinic Clinical Trials	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018879	Ventricular Premature Complexes

Ancestor Terms

ID	Term
D005117	Cardiac Complexes, Premature
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided