Mixed Reality in MitraClip Implantation: Preliminary Case Series (MIMIC)

January 10, 2025 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

Recruiting

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 (Estimated)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czech Republic
    • CZ
      • Trinec, CZ, Czech Republic, 73961
        • Recruiting
        • Hospital AGEL Trinec-Podlesi a.s.
        • Contact:
        • Contact:
        • Contact:
          • Jan Hečko, Ing., Ph.D
        • Contact:
          • Jaroslav Januška, MD, Ph.D.
        • Contact:
          • Daniel Preček, Ing

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.
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.
Other Names:
  • TEER procedure
Standard MitraClip Group
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.
Other Names:
  • TEER procedure

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
Measured pre-procedure, immediately post-procedure
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
During the MitraClip implantation procedure, measured in real-time from the start to the completion of the procedure.
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
During the MitraClip implantation procedure, measured in real-time from the start to the completion of the procedure.
Subjective assessments 1
Time Frame: Administered immediately post-procedure.
NASA TLX questionnaire with weighted score - method assesses work load on five 7-point scales
Administered immediately post-procedure.
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
Administered immediately post-procedure.
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
Administered immediately post-procedure.

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.
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.
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)
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.
Dose Area Product (DAP) through the procedure in Gy·cm²
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nemocnice AGEL Trinec-Podlesi a.s.

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 (Estimated)

December 1, 2026

Study Completion (Estimated)

December 30, 2026

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)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 10, 2025

Last Verified

August 1, 2024

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.

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