RecruitingNCT06539416

Mixed Reality in MitraClip Implantation: Preliminary Case Series

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


Sponsor

Nemocnice AGEL Trinec-Podlesi a.s.

Enrollment

14 participants

Start Date

Aug 15, 2024

Study Type

OBSERVATIONAL

Conditions

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. 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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria3

  • 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

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Interventions

PROCEDUREMitraClip implantation

The MitraClip is used to catch the leaky parts of the mitral valve, and it is tested to ensure the leak is reduced.


Locations(1)

Hospital AGEL Trinec-Podlesi a.s.

Třinec, CZ, Czechia

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NCT06539416


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