Holo CTO Proctoring Study

Assess Microsoft HoloLens as an interactive communication device in remote proctoring, and enhancement of teamwork in complex CTO procedures

Study Overview

• Status: Recruiting
• Conditions: Percutaneous Coronary Intervention; Chronic Total Occlusion of Coronary Artery
• Intervention / Treatment: Other: Remote proctoring using HoloLens

Detailed Description

Proctoring in medicine is related to better outcomes. Specifically, in CTO PCI systematic proctoring has demonstrated improved success rates, and an increased ability to treat lesions that are more complex. Most likely, proctoring together with operator volume is one of the foundations to the introduction and execution of CTO procedures. Proctoring traditionally involves an expert operator (proctor), visiting the institution, performing the procedure together with the local operator. This involves increased cost, and current travel restrictions makes traditional one-on-one proctoring challenging.

This study aims to evaluate the Microsoft HoloLens as a potential platform in proctoring and effective real time communication between PCI operators located at different geographical locations. The proctor and the local operator interact using a head mounted mixed reality (MR) display, enabling the proctor to see the same image as the operator, from any distanced location.

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

• Study Contact: Name: Slobodan Calic, MD; Phone Number: +94213644; Email: Slobodan.Calic@sshf.no
• Study Contact Backup: Name: Christian H Eek, PhD, MD; Phone Number: +4792601681; Email: sbeekc@ous-hf.no

Study Locations

• Norway
  • Agder
    • Arendal, Agder, Norway, 4808
      • Recruiting
      • Sorlandet hospital
      • Contact: Slobodan Calic, MD; Phone Number: +4794213644; Email: Slobodan.Calic@sshf.no
      • Contact: Christian H Eek, PhD,MD; Phone Number: +479260681; Email: sbeekc@ous-hf.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with coronary artery disease and total chronic occlusion of one or more coronary arteries.

Description

Inclusion Criteria:

Clinical inclusion criteria:

• Stable angina pectoris, or dyspnoea as an angina equivalent
• Age ≥18 yrs.
• Able to provide written informed consent

Angiographic inclusion criteria:

• One or more completely occluded coronary arteries with Thrombolysis In Myocardial Infarction (TIMI) flow 0. An estimated occlusion duration of at least 3 months
• Absence of Q-wave in ECG leads corresponding to the occluded vessel, or documented viability of the main territory by MRI or echocardiography

Procedural inclusion criteria:

• Clinical indication for CTO PCI regardless of operative technique

Exclusion Criteria:

• STEMI within 72 hours
• Cardiogenic shock
• Active bleeding or coagulopathy
• Life expectancy < 2 years
• Relevant allergies (aspirin, clopidrogrel, ticagrelol, contrast compounds)
• Severe peripheral artery disease
• Clinical unstable angina

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study population; Patients undergoing percutaneus coronary intervention for chronic total occlusion. The procedures will all be done using mixed reality to enable remote proctoring. The study is a feasibility trial.	Other: Remote proctoring using HoloLens; Assess Microsoft HoloLens as an interactive communication device in remote proctoring, and enhancement of teamwork in complex CTO procedures.; Other Names: Chronic total occlusion percutaneus coronary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standard Usability Score on a Likert Scale	The operators completing the intervention will rate the usability of the system on a Likert scale: The HoloLens was useful in this procedure; The HoloLens was not distracting; The HoloLens was comfortable to wear; The HoloLens camera image has sufficient quality for clinical use (not considering the fluoroscopy screen); Compared to an alternative system with fluoroscopy image plus handsfree voice (telephone), the HoloLens gives additional value during the procedure; The current solution with Remote Assist plus parallel fluoroscopy streaming is mature enough for routine use; The current solution is stable; The current solution is easy to set up prior to the procedure; I would like to continue to use the HoloLens in CTO procedures routinely when remote proctoring is needed Agree to Disagree Likert Scale; Strongly Disagree; Disagree; Neither agree nor disagree; Agree; Strongly Agree	Procedure duration( aprox 120 min)

Collaborators and Investigators

• Sponsor: Sorlandet Hospital HF
• Collaborators: Oslo University Hospital; HoloCare AS
• Investigators: Principal Investigator: Slobodan Calic, MD, Sorlandet hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): January 31, 2023

Study Registration Dates

• First Submitted: September 27, 2021
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 11, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: HoloCTO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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