Dose reduction in EP (Xres 3 vs Xres 4)

X-ray dose and image quality are intimately related by laws of physics. Low
dose and high image quality cannot be achieved at the same time. However, smart
image processing algorithms such as Xres4 can help the system achieve lower
dose without influencing image quality or achieving higher image quality with
equal dose. Xres4 is a new image processing algorithm that has the potential
to dramatically reduce noise in X-ray acquisitions. This noise reduction can be
used to lower the X-ray dose, increase sharpness and details of images, or
lower iodine (contrast material) usage without sacrificing image quality.
Xres4 algorithms were developed to address the clinical need for dose reduction
and image quality enhancement.

The primary objective of this study is to validate that the reduced system dose
setting with Xres4 translate into an overall procedure dose reduction.
Procedure dose will be determined by the cumulative dose area product (DAP)
value and the cumulative Air Kerma (AK) as measured and displayed by the Allura
Xper System.

This is a single center, randomized, unblinded parallel controlled study with
two study groups designed to compare between the Xres3 and Xres4 system
settings for EP procedures. The study groups are as follows:
1. Xres3 arm (Control): EP procedures performed using Xres3 conventional image
processing and conventional system dose settings
2. Xres4 arm (Interventie): EP procedures performed using the advanced Xres4
image processing algorithms and reduced system dose settings

NA

De intervention will be performed with CE certified equipement. Earlier studies
have indicated that the X-ray images acquired with reduced dose are adequate
for performing EP procedures. De intervention itself is otherwise not affected
by the study.

For patients in the intervention arm of this study, there is a minor risk that
the X-ray images that are made with reduced dose, are less suitable for guiding
the electrophysiological intervention. In that case it is possible the duration
of the intervention will slightly increase (estimated to be maximal in the
order of several minutes) and that as a consequence the total radiation dose
exposure will increase. It is, however, unlikely that the total radiation dose
will exceed the standard dose, because in case the X-ray images are
insufficient, the cardiologist will decide to perform the intervention with
X-ray images acquired with the standard dose.