Structural Cardiac Defects
Conditions
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.
Interventions
DEVICE3D Holographic Display
3D holographic visualization of the anatomy during the planned interventional procedure. The HOLOSCOPE-i will be used in addition to and will not replace conventional displays that are currently being used during the procedure.
Sponsors
RealView Imaging
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HOLOSCOPE-i is of clinical use for ultrasound based cardiac procedures | During procedure | Qualitative assessment using a Likert scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HOLOSCOPE-i provides an intuitive understanding of the spatial relationship of the anatomy | During procedure | Qualitative assessment using a Likert scale |
| 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 |
Countries
United States
Outcome results
None listed