EP Navigator 3D ATG Learning Curve Evaluation

Philips Healthcare has introduced EP navigator with 3D ATG that allows the
overlay of a 3D model of the left atrial anatomy on fluoroscopic images to
guide atrial fibrillation catheter ablation. This 3D model is generated from a
rotational X-ray scan by a Philips Allura XperCT FD 10 system (3D atriography
or 3D ATG). This investigation aims at measuring the single site learning curve
to use EP navigator and 3D ATG. A secondary aim is to assess whether at the end
of the learning curve total procedure time is longer, shorter or equal to
ablation procedures guided by means of conventional navigation systems such as
Carto and NavX.

To document a single centre learning curve to use 3D ATG overlay with catheter
position tagging to assist atrial fibrillation ablation procedures.

To compare use of 3D ATG overlay and the tagging tool contemporary
mapping/localisation tools (Carto or NacX) to guide atrial fibrillation
ablation in terms of procedure time, fluoroscopy time, X-ray dose, contrast
dose at the start of the learning curve and at the end of the learning curve of
using 3D ATG overlay.

To test the hypothesis that total procedure time when employing 3D ATG is
decreasing with the number of procedures to a level comparable or below total
procedure time when employing establihed methods (Carto or NavX).

This investigation is single site clinical evaluation of existing and approved
software. Patients will be randomized to the 3D ATG overlay guided groups and
the control group in a 1 to 1 fashion.

Increased exposure to X-ray and contrast could occur. In standard procedures 60
ml of contrast is required compared to 100 ml in the 3D ATG group. It is
uncertain if any increased X-ray exposure will occur in the 3D ATG group. If,
after the leasrning curve is over, CT-scan can be omitted, 3D ATG will surely
reduce overall X-ray exposure. For 3D ATG it is not necessary to introduce
additional catheter in the sheats.