Mitral Regurgitation
Conditions
Keywords
MitraClip,, MixedReality, Hololens, DICOM, Rendering, Support
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREMitraClip implantation
The MitraClip is used to catch the leaky parts of the mitral valve, and it is tested to ensure the leak is reduced.
Sponsors
Nemocnice AGEL Trinec-Podlesi a.s.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged over 18 years * Patients diagnosed with mitral valve regurgitation requiring MitraClip implantation * Ability to provide informed consent and comply with study procedures
Exclusion criteria
* Patients with contraindications for MR technology (e.g., MRI incompatibility) * Individuals unable to comply with study procedures due to physical or cognitive impairments * Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operator stress indicator 1 | Measured pre-procedure, immediately post-procedure | difference of cortisol levels in mmol/l |
| Operator stress indicator 2 | During the MitraClip implantation procedure, measured in real-time from the start to the completion of the procedure. | heart rate variability of operator in BPM |
| Operator stress indicators 3 | During the MitraClip implantation procedure, measured in real-time from the start to the completion of the procedure. | QTc interval in ms |
| Subjective assessments 1 | Administered immediately post-procedure. | NASA TLX questionnaire with weighted score - method assesses work load on five 7-point scales |
| Subjective assessments 2 | Administered immediately post-procedure. | STAI Y questionnaire with varies from a minimum score of 20 to a maximum score of 80 |
| Subjective assessments 3 | Administered immediately post-procedure. | SSQ questionnaire with assign a score from 0-3 for each of the sixteen items on the SSQ |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural efficiency | 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. | time of procedure |
| Radiation time exposure | 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. | Fluoroscopy Time (in minutes) |
| Radiation dose exposure | 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. | Dose Area Product (DAP) through the procedure in Gy·cm² |
Countries
Czechia
Contacts
STUDY_DIRECTOROtakar Jiravsky, MD
Hospital Agel Trinec-Podlesi
Outcome results
None listed