Three-dimensional (3D) Holographic Display for Ultrasound-Guided Structural Heart Disease Procedures

• Conditions: Structural Cardiac Defects

• Registration Number: NCT05514626
• Lead Sponsor: RealView Imaging

Brief Summary

This study is intended to evaluate the use of the holographic display of 3D images acquired during ultrasound based cardiac procedures and to assess the clinical use of the HOLOSCOPE-i, in providing 3D spatial understanding to the clinician performing the procedure. Patients scheduled to undergo an elective procedure in the Cardiac Catheterization Laboratory which use 3D echocardiography (ECHO) as part of the procedure will be enrolled to this study. In addition to the standard of practice imaging using ultrasound, patients anatomical structures will be evaluated using a 3D holographic system. The patients will complete their participation in the study, at the end of the procedure. No follow-up is required and patients will continue their routine medical care following the procedure.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-24
• Status Verified: 2022-08
• Study First Submitted: 2022-08-22
• Study First Submitted QC: 2022-08-22
• Last Update Submitted: 2022-08-22
• Study First Posted: 2022-08-24
• Last Update Posted: 2022-08-24
• Primary Completion: 2023-03-15
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients over the age of 18
• Patients are scheduled to undergo an elective procedure in the Cardiac Catheterization Laboratory which use 3D echocardiography (ECHO) as part of the procedure.

Exclusion Criteria

• Denial of informed consent
• Any contraindications to three-dimensional echocardiographic imaging.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HOLOSCOPE-i is of clinical use for ultrasound based cardiac procedures	During procedure	Qualitative assessment using a Likert scale

Secondary Outcome Measures

Name	Time	Method
HOLOSCOPE-i provides an intuitive understanding of the spatial relationship between the tool and the anatomy	During procedure	Qualitative assessment using a Likert scale
Satisfaction with the use of the HOLOSCOPE-i under intra-procedural conditions	During procedure	Qualitative assessment using a Likert scale
HOLOSCOPE-i provides an intuitive understanding of the spatial relationship of the anatomy	During procedure	Qualitative assessment using a Likert scale

Trial Locations

Locations (1)

New York Presbyterian; 🇺🇸 New York, New York, United States