Mixed Reality in MitraClip Implantation: Preliminary Case Series

NCT06539416 | Recruiting

• 1 other identifier: INT2021011
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mitral Regurgitation

Keywords

MitraClip,; MixedReality; Hololens; DICOM; Rendering; Support

Outcome Measures

Primary Outcomes (6)

• Operator stress indicator 1

  difference of cortisol levels in mmol/l

  Measured pre-procedure, immediately post-procedure

• Operator stress indicator 2

  heart rate variability of operator in BPM

  During the MitraClip implantation procedure, measured in real-time from the start to the completion of the procedure.

• Operator stress indicators 3

  QTc interval in ms

  During the MitraClip implantation procedure, measured in real-time from the start to the completion of the procedure.

• Subjective assessments 1

  NASA TLX questionnaire with weighted score - method assesses work load on five 7-point scales

  Administered immediately post-procedure.

• Subjective assessments 2

  STAI Y questionnaire with varies from a minimum score of 20 to a maximum score of 80

  Administered immediately post-procedure.

• Subjective assessments 3

  SSQ questionnaire with assign a score from 0-3 for each of the sixteen items on the SSQ

  Administered immediately post-procedure.

Secondary Outcomes (3)

• Procedural efficiency

  From the beginning of the MitraClip implantation procedure until the completion of the procedure, measured in real-time, typically ranging from 1 to 3 hours.

• Radiation time exposure

  From the start of the MitraClip implantation procedure until the end of fluoroscopy use, measured in real-time throughout the duration of the procedure, typically ranging from 30 to 120 minutes.

• Radiation dose exposure

  From the start of the MitraClip implantation procedure until the end of fluoroscopy use, measured in real-time throughout the duration of the procedure, typically ranging from 30 to 120 minutes.

Study Arms (2)

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.

Procedure: MitraClip implantation

Standard MitraClip Group

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

Procedure: MitraClip implantation

Interventions

MitraClip implantation PROCEDURE

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

Also known as: TEER procedure

Mixed Reality (MR) Assisted MitraClip Group; Standard MitraClip Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population comprises adult patients aged over 18 who require MitraClip implantation for the treatment of mitral valve regurgitation. These patients are selected from the patient pool at Hospital AGEL Trinec-Podlesi, Trinec, Czechia.

You may qualify if:

• Adults aged over 18 years
• Patients diagnosed with mitral valve regurgitation requiring MitraClip implantation
• Ability to provide informed consent and comply with study procedures

You may not qualify if:

• 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

Sponsors & Collaborators

• Nemocnice AGEL Trinec-Podlesi a.s.: lead

Study Sites (1)

Hospital AGEL Trinec-Podlesi a.s.

Třinec, CZ, 73961, Czechia

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Otakar Jiravsky, MD

  Hospital Agel Trinec-Podlesi

  STUDY DIRECTOR

Central Study Contacts

Jan Hecko, Ing, Ph.D.

CONTACT

+420602416905; jan.hecko@npo.agel.cz

Otakar Jiravsky, MD

CONTACT

+420602579193; otakar.jiravsky@npo.agel.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead Biomedical Engineer

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 6, 2024
• Study Start: August 15, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 13, 2025

Record last verified: 2024-08

Locations

CZ (1)