Cardiac Vascular Reconstruction DynaCT for TAVI Procedures
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/10/2019 |
| Start Date: | February 2014 |
| End Date: | October 17, 2017 |
Cardiac Vascular Reconstruction (CAVAREC) DynaCT for 3D Assessment of Aortic Valve During TAVI Procedures
The purpose of this work is to evaluate the feasibility of a new Cardiac Vascular
Reconstruction (CAVAREC, Siemens Medical Systems, Germany) image reconstruction algorithm for
use during transcatheter aortic valve implant (TAVI) procedures or interventional procedures
to treat congenital or structural heart disease. CAVAREC utilizes the same x-ray projection
images as currently acquired for clinical DynaCT. X-ray image acquisition to allow CAVAREC
will occur during the interventional procedure after the TAVI device, other valve, or stent
is implanted. If the participants already have a surgically-implanted TAVI device, stent or
other device, and are having a cardiac catheterization, then an extra set of images will be
acquired after your clinical care is complete, but before you leave the procedure room. The
CAVAREC image processing algorithm will be implemented on an off-line workstation after the
interventional procedure is complete. After the TAVI procedure, CAVAREC images will be
quantitatively and qualitatively compared to Siemens DynaCT and cardiac CT images from
Radiology. The results of this study will be used to direct further development of CAVAREC
toward the end goal of providing improved imaging capabilities to guide TAVI, congenital
heart, or structural heart treatment procedures.
Reconstruction (CAVAREC, Siemens Medical Systems, Germany) image reconstruction algorithm for
use during transcatheter aortic valve implant (TAVI) procedures or interventional procedures
to treat congenital or structural heart disease. CAVAREC utilizes the same x-ray projection
images as currently acquired for clinical DynaCT. X-ray image acquisition to allow CAVAREC
will occur during the interventional procedure after the TAVI device, other valve, or stent
is implanted. If the participants already have a surgically-implanted TAVI device, stent or
other device, and are having a cardiac catheterization, then an extra set of images will be
acquired after your clinical care is complete, but before you leave the procedure room. The
CAVAREC image processing algorithm will be implemented on an off-line workstation after the
interventional procedure is complete. After the TAVI procedure, CAVAREC images will be
quantitatively and qualitatively compared to Siemens DynaCT and cardiac CT images from
Radiology. The results of this study will be used to direct further development of CAVAREC
toward the end goal of providing improved imaging capabilities to guide TAVI, congenital
heart, or structural heart treatment procedures.
1. Compare utility of CAVAREC to standard DynaCT and cardiac CT for clinical assessment of
the aortic valve and relevant, nearby anatomical structures.
2. Investigate the utility of CAVAREC to assess calcification within and surrounding the
native aortic valve.
3. Investigate the utility of CAVAREC to assess procedural success, including prosthetic
valve placement and annular anatomic correlates of paravalvular leak.
4. Validate utility of CAVAREC for images acquired during normal sinus rhythm.
the aortic valve and relevant, nearby anatomical structures.
2. Investigate the utility of CAVAREC to assess calcification within and surrounding the
native aortic valve.
3. Investigate the utility of CAVAREC to assess procedural success, including prosthetic
valve placement and annular anatomic correlates of paravalvular leak.
4. Validate utility of CAVAREC for images acquired during normal sinus rhythm.
Inclusion Criteria:
- Patients may either be scheduled for a TAVI procedure or scheduled for a cath lab
appointment at any time after a TAVI procedure, or scheduled for device implant to
treat congenital or structural heart disease.
Exclusion Criteria:
- Patient enrolled in research protocol with exclusions from simultaneous participation
in another protocol
- Lack of research consent.
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