TAVR Planning CT for a Pivotal Trial

Challenge

A transcatheter aortic valve replacement trial depended on precise annular measurements and access-route assessment from ECG-gated cardiac CT, yet participating sites varied widely in acquisition technique and reconstruction practice. Inconsistent gating, slice thickness, and contrast timing produced measurements that could not be compared reliably across subjects, and several sites had never performed protocol-specified cardiac CT. The sponsor needed uniform, measurement-grade imaging from every site without delaying enrollment.

Our Solution

Intrinsic Imaging developed a detailed acquisition protocol with site-specific implementation support, including hands-on technologist training and phantom-based qualification before any subject was scanned. Every cardiac CT underwent central quality control within 24 hours of upload, with immediate reacquisition guidance where motion artifact or timing errors compromised measurement quality. Subspecialty cardiac imagers performed annular sizing, coronary height assessment, and peripheral access evaluation under a standardized measurement charter, with dual measurement of borderline cases.

Results

• 98% of examinations accepted on first submission
• Measurement reproducibility within 1 mm between readers
• Zero enrollment delays attributable to imaging