Mayo Clinic
Rochester, Minnesota, 55905, United States
NCT Number: NCT02031796
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Rochester, Minnesota, 55905, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After deployment of the TAVI prosthesis, other trans catheter valve, or stent, but before the patient care episode is completed, a set of rotational x-ray angiography images will be acquired and reconstructed using the clinical DyanCT and research CAVAREC algorithms.
Time frame: approx 2 hours after surgery
Qualitative image assessment will be performed by Board Certified Cardiologists and/or Radiologists who are familiar with cardiac CT image manipulation and interpretation.
Mayo Clinic
Other
Cardiac Vascular Reconstruction (CAVAREC) DynaCT for 3D Assessment of Aortic Valve During TAVI Procedures
Acronym: CAVAREC
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