Holo CTO Proctoring Study

Percutaneous Coronary Intervention Clinical Trial

Official title:

Holo CTO Proctoring Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05377866
• Other study ID #: HoloCTO
• Status: Completed
• Start date: November 4, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: September 2021
• Source: Sorlandet Hospital HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Total Occlusion of Coronary Artery
• Percutaneous Coronary Intervention

Intervention

Other:
• Remote proctoring using HoloLens
Assess Microsoft HoloLens as an interactive communication device in remote proctoring, and enhancement of teamwork in complex CTO procedures.

Locations

Country	Name	City	State
Norway	Sorlandet Hospital	Arendal	Agder

Sponsors (3)

Lead Sponsor	Collaborator
Sorlandet Hospital HF	HoloCare AS, Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)