Mixed Reality in MitraClip Implantation: Preliminary Case Series (MIMIC)
July 28, 2026 updated by: Ing. Jan Hečko, Nemocnice AGEL Trinec-Podlesi a.s.
Leveraging Mixed Reality in MitraClip Implantation: A Preliminary Case Series Toward a Pilot Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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CZ
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Třinec, CZ, Czechia, 73961
- Hospital AGEL Trinec-Podlesi a.s.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
The MitraClip is used to catch the leaky parts of the mitral valve, and it is tested to ensure the leak is reduced.
Other Names:
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Standard MitraClip Group
Patients undergoing MitraClip implantation using standard procedural methods without the assistance of MR technology.
|
The MitraClip is used to catch the leaky parts of the mitral valve, and it is tested to ensure the leak is reduced.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Operator stress indicator 1
Time Frame: Measured pre-procedure, immediately post-procedure
|
difference of cortisol levels in mmol/l
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Measured pre-procedure, immediately post-procedure
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Operator stress indicator 2
Time Frame: During the MitraClip implantation procedure, measured in real-time from the start to the completion of the procedure.
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heart rate variability of operator in BPM
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During the MitraClip implantation procedure, measured in real-time from the start to the completion of the procedure.
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Operator stress indicators 3
Time Frame: During the MitraClip implantation procedure, measured in real-time from the start to the completion of the procedure.
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QTc interval in ms
|
During the MitraClip implantation procedure, measured in real-time from the start to the completion of the procedure.
|
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Subjective assessments 1
Time Frame: Administered immediately post-procedure.
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NASA TLX questionnaire with weighted score - method assesses work load on five 7-point scales
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Administered immediately post-procedure.
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Subjective assessments 2
Time Frame: Administered immediately post-procedure.
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STAI Y questionnaire with varies from a minimum score of 20 to a maximum score of 80
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Administered immediately post-procedure.
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Subjective assessments 3
Time Frame: Administered immediately post-procedure.
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SSQ questionnaire with assign a score from 0-3 for each of the sixteen items on the SSQ
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Administered immediately post-procedure.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Procedural efficiency
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.
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time of procedure
|
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.
|
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Radiation time exposure
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.
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Fluoroscopy Time (in minutes)
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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.
|
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Radiation dose exposure
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.
|
Dose Area Product (DAP) through the procedure in Gy·cm²
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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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Otakar Jiravsky, MD, Hospital Agel Trinec-Podlesi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 15, 2024
Primary Completion (Actual)
September 30, 2025
Study Completion (Actual)
September 30, 2025
Study Registration Dates
First Submitted
July 25, 2024
First Submitted That Met QC Criteria
August 1, 2024
First Posted (Actual)
August 6, 2024
Study Record Updates
Last Update Posted (Actual)
July 30, 2026
Last Update Submitted That Met QC Criteria
July 28, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- INT2021011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
The study plans to share de-identified individual participant data (IPD) to facilitate transparency and further research in the field of interventional cardiology and mixed reality (MR) technology applications.
The shared data will be stripped of any personal identifiers to maintain participant confidentiality and adhere to data protection regulations.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.