Using mixed reality technology to assist in MitraClip implantation
Leveraging Mixed Reality in MitraClip Implantation: a Preliminary Case Series Toward a Pilot Study
This study tests if using mixed reality technology can make MitraClip implantation safer and easier for patients with mitral regurgitation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 14 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nemocnice AGEL Trinec-Podlesi a.s. Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Třinec, CZ) |
| Trial ID | NCT06539416 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of mixed reality (MR) technology, specifically Hololens 2.0, on the efficiency and safety of MitraClip implantation procedures for patients with mitral regurgitation. It involves a preliminary case series of four implantations, where procedural efficiency, radiation exposure, and operator stress are assessed through both physiological and subjective measures. The goal is to determine how MR can enhance precision and spatial awareness during these interventional cardiology procedures.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years diagnosed with mitral valve regurgitation who require MitraClip implantation.
Not a fit: Patients with contraindications for MR technology or those unable to comply with study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the safety and effectiveness of MitraClip procedures for patients with mitral regurgitation.
How similar studies have performed: While the use of mixed reality in medical procedures is emerging, this specific application in MitraClip implantation is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Třinec, CZ
- Hospital AGEL Trinec-Podlesi a.s. — Třinec, Cz, Czechia (Recruiting)
Study contacts
- Study coordinator: Jan Hecko, Ing, Ph.D.
- Email: jan.hecko@npo.agel.cz
- Phone: +420602416905
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.