Cardiac Vascular Reconstruction DynaCT for TAVI Procedures

Completed · Not applicable

Conditions studied: Aortic Valve Disease

In brief

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.

Key facts

Study ID

NCT02031796

Run by

Mayo Clinic

People needed

35

Starts

2014-02-01

Expected to finish

2017-10-17

Last updated by the study team

2019-01-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patient enrolled in research protocol with exclusions from simultaneous participation in another protocol
• Lack of research consent.

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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