Mixed Reality in MitraClip Implantation: Preliminary Case Series
- Conditions
- Mitral Regurgitation
- Interventions
- Procedure: MitraClip implantation
- Registration Number
- NCT06539416
- Lead Sponsor
- Nemocnice AGEL Trinec-Podlesi a.s.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 14
- Adults aged over 18 years
- Patients diagnosed with mitral valve regurgitation requiring MitraClip implantation
- Ability to provide informed consent and comply with study procedures
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Standard MitraClip Group MitraClip implantation Patients undergoing MitraClip implantation using standard procedural methods without the assistance of MR technology. Mixed Reality (MR) Assisted MitraClip Group MitraClip implantation Patients undergoing MitraClip implantation with the assistance of MR technology, using Hololens 2.0 for three-dimensional visualization of DICOM images to enhance procedural precision and operator spatial awareness.
- Primary Outcome Measures
Name Time Method Subjective assessments 1 Administered immediately post-procedure. NASA TLX questionnaire with weighted score - method assesses work load on five 7-point scales
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
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 2 Administered immediately post-procedure. STAI Y questionnaire with varies from a minimum score of 20 to a maximum score of 80
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
- Secondary Outcome Measures
Name Time Method 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)
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 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
Trial Locations
- Locations (1)
Hospital AGEL Trinec-Podlesi a.s.
🇨🇿Trinec, CZ, Czech Republic