Cardiac Vascular Reconstruction DynaCT for TAVI Procedures

Aortic Valve Disease Clinical Trial

— CAVAREC  

Official title:

Cardiac Vascular Reconstruction (CAVAREC) DynaCT for 3D Assessment of Aortic Valve During TAVI Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02031796
• Other study ID #: 13-004257
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: October 17, 2017

Study information

• Verified date: January 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 17, 2017
• Est. primary completion date: October 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Disease

Intervention

Other:
• CAVAREC Image Processing algorithm
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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Siemens Medical Solutions USA - CSG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of images of the aortic valve that are accurate	Qualitative image assessment will be performed by Board Certified Cardiologists and/or Radiologists who are familiar with cardiac CT image manipulation and interpretation.	approx 2 hours after surgery