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Completed

NCT Number: NCT06539416

Mixed Reality in MitraClip Implantation: Preliminary Case Series

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.

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Key information

Conditions

Mitral Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital AGEL Trinec-Podlesi a.s.

Třinec, CZ, 73961, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MitraClip implantation

Procedure

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: TEER procedure

Primary outcomes

  1. Operator stress indicator 1

    Time frame: Measured pre-procedure, immediately post-procedure

    difference of cortisol levels in mmol/l

  2. 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

  3. 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

  4. Subjective assessments 1

    Time frame: Administered immediately post-procedure.

    NASA TLX questionnaire with weighted score - method assesses work load on five 7-point scales

  5. 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

  6. 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

Secondary outcomes

  1. 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.

    time of procedure

  2. 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.

    Fluoroscopy Time (in minutes)

  3. 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

Sponsors and collaborators

Lead sponsor

Nemocnice AGEL Trinec-Podlesi a.s.

Other

Registry information

Official study title

Leveraging Mixed Reality in MitraClip Implantation: A Preliminary Case Series Toward a Pilot Study

Acronym: MIMIC

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 6, 2024
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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