Mitral RegurgitationMIMICNCT06539416
Mixed Reality in MitraClip Implantation: Preliminary Case Series
An observational study of Mitral Regurgitation, run by Nemocnice AGEL Trinec-Podlesi a.s. at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- MitraClip implantation
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteCzechia
- Study dates
- 15 Aug 2024to 30 Sep 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adults aged over 18 years
- Patients diagnosed with mitral valve regurgitation requiring MitraClip implantation
- Ability to provide informed consent and comply with study procedures
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mitral Regurgitation
- Being tested
- MitraClip implantation
- Keywords
- MitraClip,, MixedReality, Hololens, DICOM, Rendering, Support
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitraClip implantationProcedure or surgery
Also called TEER procedure
The MitraClip is used to catch the leaky parts of the mitral valve, and it is tested to ensure the leak is reduced.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: MitraClip implantation | |
| Standard MitraClip Group | Patients undergoing MitraClip implantation using standard procedural methods without the assistance of MR technology. Receives: Procedure: MitraClip implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operator stress indicator 1
difference of cortisol levels in mmol/l
Measured: Measured pre-procedure, immediately post-procedure
Operator stress indicator 2
heart rate variability of operator in BPM
Measured: During the MitraClip implantation procedure, measured in real-time from the start to the completion of the procedure.
Operator stress indicators 3
QTc interval in ms
Measured: During the MitraClip implantation procedure, measured in real-time from the start to the completion of the procedure.
Subjective assessments 1
NASA TLX questionnaire with weighted score - method assesses work load on five 7-point scales
Measured: Administered immediately post-procedure.
Subjective assessments 2
STAI Y questionnaire with varies from a minimum score of 20 to a maximum score of 80
Measured: Administered immediately post-procedure.
Subjective assessments 3
SSQ questionnaire with assign a score from 0-3 for each of the sixteen items on the SSQ
Measured: Administered immediately post-procedure.
Secondary outcomes (3)
Procedural efficiency
time of procedure
Measured: 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 time exposure
Fluoroscopy Time (in minutes)
Measured: 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.
Radiation dose exposure
Dose Area Product (DAP) through the procedure in Gy·cm²
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start15 Aug 2024
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Nemocnice AGEL Trinec-Podlesi a.s.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ing. Jan Hečko, Nemocnice AGEL Trinec-Podlesi a.s.
- Investigators
- Otakar Jiravsky, MD, Study director, Hospital Agel Trinec-Podlesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539416
- Sponsor's protocol ID
- INT2021011
- Acronym
- MIMIC
- Status last verified
- Jul 2026
- First submitted
- 25 Jul 2024
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Mixed Reality in MitraClip Implantation: A Preliminary Case Series Toward a Pilot Study
- ClinicalTrials.gov ID
- NCT06539416
- Acronym / sponsor ID
- MIMIC / INT2021011
- Conditions
- Mitral Regurgitation
- Keywords
- MitraClip,, MixedReality, Hololens, DICOM, Rendering, Support
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nemocnice AGEL Trinec-Podlesi a.s.University, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mixed Reality (MR) Assisted MitraClip Group | – | Procedure: MitraClip implantationPatients 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. |
| Standard MitraClip Group | – | Procedure: MitraClip implantationPatients undergoing MitraClip implantation using standard procedural methods without the assistance of MR technology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Adults aged over 18 years
- Patients diagnosed with mitral valve regurgitation requiring MitraClip implantation
- Ability to provide informed consent and comply with study procedures
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MitraClip implantationAlso: TEER procedureThe MitraClip is used to catch the leaky parts of the mitral valve, and it is tested to ensure the leak is reduced. | Procedure or surgery | Mixed Reality (MR) Assisted MitraClip Group, Standard MitraClip Group |
Primary outcome
Operator stress indicator 1
Time frame: Measured pre-procedure, immediately post-procedure
difference of cortisol levels in mmol/l
Operator stress indicator 2
Time frame: 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
Operator stress indicators 3
Time frame: During the MitraClip implantation procedure, measured in real-time from the start to the completion of the procedure.
QTc interval in ms
Subjective assessments 1
Time frame: Administered immediately post-procedure.
NASA TLX questionnaire with weighted score - method assesses work load on five 7-point scales
Subjective assessments 2
Time frame: Administered immediately post-procedure.
STAI Y questionnaire with varies from a minimum score of 20 to a maximum score of 80
Subjective assessments 3
Time frame: Administered immediately post-procedure.
SSQ questionnaire with assign a score from 0-3 for each of the sixteen items on the SSQ
3 secondary outcomes
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Otakar Jiravsky, MD study director
Hospital Agel Trinec-Podlesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Regurgitation, run by Nemocnice AGEL Trinec-Podlesi a.s. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operator stress indicator 1 (time frame: Measured pre-procedure, immediately post-procedure). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.