Holo CTO Proctoring Study

Sorlandet Hospital HF

Status: Completed

Conditions: Percutaneous Coronary Intervention; Chronic Total Occlusion of Coronary Artery

Treatments: Other: Remote proctoring using HoloLens

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05377866

HoloCTO

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

10 participants in 1 patient group

Study population

Description:

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.

Treatment:

Other: Remote proctoring using HoloLens