Cardiac Vascular Reconstruction DynaCT for TAVI Procedures

Not Applicable

Completed

• Conditions: Aortic Valve Disease
• Interventions: Other: CAVAREC Image Processing algorithm

• Registration Number: NCT02031796
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2014-01-07
• Study First Submitted QC: 2014-01-07
• Study First Posted: 2014-01-09
• Study Start: 2014-02
• Status Verified: 2016-01
• Primary Completion: 2017-10-13
• Study Completion: 2017-10-17
• Last Update Submitted: 2019-01-04
• Last Update Posted: 2019-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CAVAREC images	CAVAREC Image Processing algorithm	CAVAREC images from x-ray angiography

Primary Outcome Measures

Name	Time	Method
Number of images of the aortic valve that are accurate	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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States