X-ray Dose Reduction in Electrophysiology
Allura Clarity is a novel X-ray imaging technology, that combines advanced real-time image noise reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose significantly. This is realized by anatomy-specific optimization of the full acquisition chain (grid switch, beam filtering, pulse width, spot size, detector and image processing engine) for every clinical task individually. Furthermore, smaller focal spot sizes and shorter pulses are used, which are known to positively influence image quality .
The primary aim of this study is to verify if a significant reduction in total procedural X-ray dose during electrophysiological interventions can be achieved by using advanced image processing (Allura Clarity).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||X-ray Dose Reduction in Electrophysiology|
- Cumulative Dose Area Product (DAP) Value [ Time Frame: Day 0 ] [ Designated as safety issue: No ]Percentage reduction of reduced X-ray dose settings (Allura Clarity) vs. regular X-ray dose settings (AlluraXper) in DAP.
- Cumulative Air Kerma (AK) Value [ Time Frame: Day 0 ] [ Designated as safety issue: No ]Percentage reduction of reducted X-ray dose settings (Allura Clarity) vs. regular X-ray dose settings (AlluraXper) in AK.
- Staff Dose Measured by DoseAware and Electronic Personal Dosimeter (EPD) [ Time Frame: Day 0 ] [ Designated as safety issue: No ]Staff dose measured by Electronic Personal Dosimeter (EPD) worn by the operator over the lead apron (EPD operator) and the other mounted at a fixed location in the EP laboratory (EPD fixed)
- Physician Professional Judgment on Procedural Success [ Time Frame: Day 0 ] [ Designated as safety issue: No ]Measurement of professional judgment (yes/no) of the treating physician.
- Procedure Duration [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
- Fluoro and Exposure Times [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
- Physician Professional Judgment on Adequacy of Images for Performing the EP Procedure [ Time Frame: Day 0 ] [ Designated as safety issue: No ]If fluoroscopy time (see results in other secondary outcomes), number of exposure frames (see below) and procedure duration (see results in other secondary outcomes) are equivalent between the two groups, this will indicate that image quality (IQ) is equally adequate in both groups.
- Usage of Physician Controlled Dose Settings [ Time Frame: Day 0 ] [ Designated as safety issue: No ]In both groups, default fluoroscopy dose settings were 'low', but could be changed by the operator to a medium or high setting for better imaging. The necessity to increase fluoroscopy dose for better imaging to medium or high was registered as a percentage of total number of fluoroscopy frames.
- Serious Adverse Events [ Time Frame: Day 0 if any ] [ Designated as safety issue: No ]
|Study Start Date:||April 2012|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
No Intervention: Regular X-ray dose settings
For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
Experimental: Reduced X-ray dose settings
For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing
Radiation: Advanced image processing
Acquisition of x-ray images with reduced X-ray dose and advanced image processing
X-ray dose and image quality are related by laws of physics. Low dose and high image quality cannot be achieved at the same time. However, image processing algorithms can help an x-ray system to acquire images with lower dose without influencing image quality or achieving higher image quality with equal dose.
In order to introduce a dose reduction technology the most important aspect is to validate the diagnostic image information. Philips has developed a new algorithm that is capable to process images with similar image quality but acquired at lower dose.
|Eindhoven, Netherlands, 5623 EJ|
|Principal Investigator:||Lukas Dekker, MD, PhD||Catharina Ziekenhuis Eindhoven|