Mixed Reality in MitraClip Implantation: Preliminary Case Series
NCT ID: NCT06539416
Last Updated: 2025-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
14 participants
OBSERVATIONAL
2024-08-15
2026-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Standard MitraClip Group
Patients undergoing MitraClip implantation using standard procedural methods without the assistance of MR technology.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients diagnosed with mitral valve regurgitation requiring MitraClip implantation
* Ability to provide informed consent and comply with study procedures
Exclusion Criteria
* Individuals unable to comply with study procedures due to physical or cognitive impairments
* Pregnant or breastfeeding women
18 Years
ALL
No
Sponsors
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Nemocnice AGEL Trinec-Podlesi a.s.
OTHER
Responsible Party
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Ing. Jan Hečko
Lead Biomedical Engineer
Principal Investigators
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Otakar Jiravsky, MD
Role: STUDY_DIRECTOR
Hospital Agel Trinec-Podlesi
Locations
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Hospital AGEL Trinec-Podlesi a.s.
Třinec, CZ, Czechia
Countries
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Central Contacts
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Facility Contacts
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Jan Hečko, Ing., Ph.D
Role: backup
Jaroslav Januška, MD, Ph.D.
Role: backup
Daniel Preček, Ing
Role: backup
Other Identifiers
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INT2021011
Identifier Type: -
Identifier Source: org_study_id
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