An observational study in Mitral Regurgitation, sponsored by Nemocnice AGEL Trinec-Podlesi a.s.. Completed at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Nemocnice AGEL Trinec-Podlesi a.s. · Observational
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.
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.
468 studies on the registry are indexed under Mitral Valve Insufficiency; 164 are open to participants now.
This study's enrollment of 20 is below the median of 157 across 168 observational studies indexed under Mitral Valve Insufficiency.
Browse Mitral Valve Insufficiency studies →Nemocnice AGEL Trinec-Podlesi a.s. is the lead sponsor of 9 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: MitraClip implantation
Patients undergoing MitraClip implantation using standard procedural methods without the assistance of MR technology.
Procedure: MitraClip implantation
The MitraClip is used to catch the leaky parts of the mitral valve, and it is tested to ensure the leak is reduced.
Also known as: TEER procedure
Operator stress indicator 1
difference of cortisol levels in mmol/l
Time frame: Measured pre-procedure, immediately post-procedure
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.
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.
Subjective assessments 1
NASA TLX questionnaire with weighted score - method assesses work load on five 7-point scales
Time frame: Administered immediately post-procedure.
Subjective assessments 2
STAI Y questionnaire with varies from a minimum score of 20 to a maximum score of 80
Time frame: 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
Time frame: Administered immediately post-procedure.
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.
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.
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.
Plan to share: 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.
No publications or documents are linked to this record.
Ran from Aug 2024 to primary completion in Sep 2025, 13 months.
Of 72 non-industry observational studies under Mitral Valve Insufficiency, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 192. This study's 13 months is below that.
Counting every sponsor, half of 84 studies reached it within 57 months; a quarter within 26 and three quarters within 192.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Nemocnice AGEL Trinec-Podlesi a.s.