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

RealView Imaging

Status: Invitation-only

Conditions: Structural Cardiac Defects

Treatments: Device: 3D Holographic Display

Study type: Observational

Funder types: Industry

Identifiers

NCT05514626

20-14-001

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.