NCT06539416

Mixed Reality in MitraClip Implantation: Preliminary Case Series

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 14 (estimated)
• Sponsor: Nemocnice AGEL Trinec-Podlesi a.s. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Mitral Regurgitation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-08-15
• Primary completion: 2026-12-01
• Completion: 2026-12-30
• First posted: 2024-08-06
• Last updated: 2025-01-13

Locations

1 site across 1 country: Czechia