Leveraging Mixed Reality in MitraClip Implantation: A Preliminary Case Series Toward a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Operator stress indicators 3
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged over 18 years
- •Patients diagnosed with mitral valve regurgitation requiring MitraClip implantation
- •Ability to provide informed consent and comply with study procedures
排除标准
- •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
研究组 & 干预措施
Mixed Reality (MR) Assisted MitraClip Group
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.
干预措施: MitraClip implantation (Procedure)
Standard MitraClip Group
Patients undergoing MitraClip implantation using standard procedural methods without the assistance of MR technology.
干预措施: MitraClip implantation (Procedure)
结局指标
主要结局
Operator stress indicators 3
时间窗: 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
时间窗: 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
时间窗: Measured pre-procedure, immediately post-procedure
difference of cortisol levels in mmol/l
Operator stress indicator 2
时间窗: 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
Subjective assessments 1
时间窗: Administered immediately post-procedure.
NASA TLX questionnaire with weighted score - method assesses work load on five 7-point scales
Subjective assessments 3
时间窗: Administered immediately post-procedure.
SSQ questionnaire with assign a score from 0-3 for each of the sixteen items on the SSQ
次要结局
- 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.)
- 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.)
- 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.)
研究者
Ing. Jan Hečko
Lead Biomedical Engineer
Nemocnice AGEL Trinec-Podlesi a.s.