Mixed Reality in MitraClip Implantation: Preliminary Case Series
ConditionMitral Regurgitation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNemocnice AGEL Trinec-Podlesi a.s.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged over 18 years
Patients diagnosed with mitral valve regurgitation requiring MitraClip implantation
Ability to provide informed consent and comply with study procedures
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
MitraClip implantation
Procedure/SurgeryThe MitraClip is used to catch the leaky parts of the mitral valve, and it is tested to ensure the leak is reduced.
Treatment groups
14 Participants
are divided into 2 treatment groupsGroup A: Mixed Reality (MR) Assisted MitraClip Group1 intervention
Group B: Standard MitraClip Group1 intervention
Trial outcomes
Primary outcomes
1
Operator stress indicator 1
difference of cortisol levels in mmol/l
Time frame
Measured pre-procedure, immediately post-procedure2
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.3
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.4
Subjective assessments 1
NASA TLX questionnaire with weighted score - method assesses work load on five 7-point scales
Time frame
Administered immediately post-procedure.Secondary outcomes
1
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.2
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.3
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.Sponsors and contacts
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Source ClinicalTrials.gov