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

Nemocnice AGEL Trinec-Podlesi a.s.

Status: Enrolling

Conditions: Mitral Regurgitation

Treatments: Procedure: MitraClip implantation

Study type: Observational

Funder types: Other

Identifiers

NCT06539416

INT2021011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

14 participants in 2 patient groups

Mixed Reality (MR) Assisted MitraClip Group

Description:

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.

Treatment:

Procedure: MitraClip implantation

Standard MitraClip Group

Description:

Patients undergoing MitraClip implantation using standard procedural methods without the assistance of MR technology.

Treatment:

Procedure: MitraClip implantation