X-ray Dose Reduction in Electrophysiology
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01593852|
Recruitment Status : Completed
First Posted : May 8, 2012
Results First Posted : January 29, 2014
Last Update Posted : March 18, 2014
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).
|Condition or disease||Intervention/treatment||Phase|
|Arrhythmias, Cardiac||Radiation: Advanced image processing Radiation: Regular image processing||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||136 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||X-ray Dose Reduction in Electrophysiology|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
Active Comparator: 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
Radiation: Regular image processing
Acquisition of x-ray images with regular X-ray dose 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
- Cumulative Dose Area Product (DAP) Value [ Time Frame: Day 0 ]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 ]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 ]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 ]Measurement of professional judgment (yes/no) of the treating physician.
- Procedure Duration [ Time Frame: Day 0 ]
- Fluoroscopy Time [ Time Frame: Day 0 ]
- Physician Professional Judgment on Adequacy of Images for Performing the EP Procedure [ Time Frame: Day 0 ]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 ]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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01593852
|Eindhoven, Netherlands, 5623 EJ|
|Principal Investigator:||Lukas Dekker, MD, PhD||Catharina Ziekenhuis Eindhoven|