Clinical trial NCT06539416: Mixed Reality in MitraClip Implantation: Preliminary Case Series
Official title: Leveraging Mixed Reality in MitraClip Implantation: a Preliminary Case Series Toward a Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mitral Regurgitation
Keywords: MitraClip,
MixedReality
Hololens
DICOM
Rendering
Support
Lead sponsor: Nemocnice AGEL Trinec-Podlesi a.s.
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population comprises adult patients aged over 18 who require MitraClip implantation for the treatment of mitral valve regurgitation. These patients are selected from the patient pool at Hospital AGEL Trinec-Podlesi, Trinec, Czechia.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Operator stress indicator 1
timeFrame: Measured pre-procedure, immediately post-procedure
measure: Operator stress indicator 2
timeFrame: During the MitraClip implantation procedure, measured in real-time from the start to the completion of the procedure.
measure: Operator stress indicators 3
timeFrame: During the MitraClip implantation procedure, measured in real-time from the start to the completion of the procedure.
measure: Subjective assessments 1
timeFrame: Administered immediately post-procedure.
measure: Subjective assessments 2
timeFrame: Administered immediately post-procedure.
measure: Subjective assessments 3
timeFrame: Administered immediately post-procedure.
Secondary outcomes:
measure: Procedural efficiency
timeFrame: 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.
measure: Radiation time exposure
timeFrame: 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.
measure: Radiation dose exposure
timeFrame: 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.
Other outcomes:
Locations:
city: Trinec
country: Czech Republic
facility: Hospital AGEL Trinec-Podlesi a.s.
state: CZ
Study officials:
affiliation: Hospital Agel Trinec-Podlesi
name: Otakar Jiravsky, MD
role: STUDY_DIRECTOR
References: