The study aims to evaluate the impact of mixed reality (MR) technology, particularly using Hololens 2.0 and specialized software for three-dimensional DICOM image visualization, on MitraClip implantation procedures. This preliminary case series includes a comparative analysis of four MitraClip implantations, assessing procedural efficiency, radiation exposure, and operator stress through both physiological and subjective measures.
The advent of mixed reality (MR) technology, especially when integrated with Hololens 2.0 and specialized software for three-dimensional DICOM image visualization, offers promising avenues for enhancing precision and spatial awareness in interventional cardiology procedures. This case series aims to preliminarily evaluate the impact of MR on MitraClip implantation processes, setting the foundation for a comprehensive pilot study.
Study Type
OBSERVATIONAL
Enrollment
14
The MitraClip is used to catch the leaky parts of the mitral valve, and it is tested to ensure the leak is reduced.
Hospital AGEL Trinec-Podlesi a.s.
Třinec, CZ, Czechia
RECRUITINGOperator stress indicator 1
difference of cortisol levels in mmol/l
Time frame: Measured pre-procedure, immediately post-procedure
Operator stress indicator 2
heart rate variability of operator in BPM
Time frame: During the MitraClip implantation procedure, measured in real-time from the start to the completion of the procedure.
Operator stress indicators 3
QTc interval in ms
Time frame: During the MitraClip implantation procedure, measured in real-time from the start to the completion of the procedure.
Subjective assessments 1
NASA TLX questionnaire with weighted score - method assesses work load on five 7-point scales
Time frame: Administered immediately post-procedure.
Subjective assessments 2
STAI Y questionnaire with varies from a minimum score of 20 to a maximum score of 80
Time frame: Administered immediately post-procedure.
Subjective assessments 3
SSQ questionnaire with assign a score from 0-3 for each of the sixteen items on the SSQ
Time frame: Administered immediately post-procedure.
Procedural efficiency
time of procedure
Time frame: From the beginning of the MitraClip implantation procedure until the completion of the procedure, measured in real-time, typically ranging from 1 to 3 hours.
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Radiation time exposure
Fluoroscopy Time (in minutes)
Time frame: From the start of the MitraClip implantation procedure until the end of fluoroscopy use, measured in real-time throughout the duration of the procedure, typically ranging from 30 to 120 minutes.
Radiation dose exposure
Dose Area Product (DAP) through the procedure in Gy·cm²
Time frame: From the start of the MitraClip implantation procedure until the end of fluoroscopy use, measured in real-time throughout the duration of the procedure, typically ranging from 30 to 120 minutes.