Milestone 1 (12 months)
By the end of year one, we will hav e implemented a real time intracardiac ARFI imaging system using the Siemens Antares scanner and the AcuNav ™ intracardiac echo catheter. The technical challenges of interfacing the imaging system to the 128 channel AcuNav catheter, reducing the ARFI scan time from 220 to 50 ms, and minimizing cardiac motion and catheter rebound motion artifacts will be solved.
Milestone 2 (18 months)
By the 18 months, we will have correlated the coagulation boundary of cardiac ablation lesions with the reduction of ARFI induced tissue movement. We will use the ARFI based ICE system in vitro to quantify changes in ARFI induced motion (elastic properties) in normal and coagulated tissue by correlating ARFI image lesion boundaries with boundaries determined by histopathological examination.
Milestone 3 (24 months)
By the end of the second year, we will have the integrated CARTO™ tracking sensor embedded in the AcuNav™ ICE catheter and will have tested its positional accuracy by comparing the ablation catheter tip location guided to a location with the combined ICE/ CARTO catheter to the position measured by CARTO alone. This test will be performed both in vitro and in vivo and will measure the registration accuracy of the integrated system.
Milestone 3 (36 months)
By the end of year 3, we will have demonstrated image guided ablation performed with ICE based ARFI. We will have performed image guided ablations in a sheep model demonstrating energy titration with real time lesion evaluation, demonstrating lesion continuity evaluation by ARFI imaging and demonstrating that our hybrid system can guide lesion line repair. Lesion extent will be compared to histological results and lesion continuity and repair will be verified by conventional electrical mapping and histological examination.