Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D Holographic Display | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| HOLOSCOPE-i is of clinical use for ultrasound based cardiac procedures | Qualitative assessment using a Likert scale | During procedure |
| Measure | Description | Time Frame |
|---|---|---|
| HOLOSCOPE-i provides an intuitive understanding of the spatial relationship of the anatomy | Qualitative assessment using a Likert scale | During procedure |
| HOLOSCOPE-i provides an intuitive understanding of the spatial relationship between the tool and the anatomy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Up to Fifty (50) patients undergoing elective procedures which use 3D echocardiography for treatment of structural heart disease.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Presbyterian | New York | New York | 10032 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Qualitative assessment using a Likert scale |
| During procedure |
| Satisfaction with the use of the HOLOSCOPE-i under intra-procedural conditions | Qualitative assessment using a Likert scale | During procedure |