X-ray Dose Reduction in Electrophysiology

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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X-ray Dose Reduction in Electrophysiology

Conditions
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Arrhythmias, Cardiac

Intervention / Treatment
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* Radiation: Advanced image processing
* Radiation: Regular image processing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with heart rhythm disturbances undergoing an interventional treatment for their heart rhythm disturbance Patients who are allowed, able, willing to and have provided informed consent Patients to be treated with ablation for atrial fibrillation (paroxysmal, persistent or permanent), atypical atrial flutter or patients to be treated with ablation for ischemic or non-ischemic ventricular tachycardia Patients who are treated in heart catheterization room 5 (HCK5) of the Catherina Hospital Exclusion Criteria: Patients under 18 years of age. Patient who are pregnant or breast feeding.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Regular X-ray dose settings<br>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<br>* Acquisition of x-ray images with regular X-ray dose and regular image processing<br>|
| Experimental: Reduced X-ray dose settings<br>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<br>* Acquisition of x-ray images with reduced X-ray dose and advanced image processing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Dose Area Product (DAP) Value | Percentage reduction of reduced X-ray dose settings (Allura Clarity) vs. regular X-ray dose settings (AlluraXper) in DAP. | Day 0 | 
| Cumulative Air Kerma (AK) Value | Percentage reduction of reducted X-ray dose settings (Allura Clarity) vs. regular X-ray dose settings (AlluraXper) in AK. | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Staff Dose Measured by DoseAware and Electronic Personal Dosimeter (EPD) | 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) | Day 0 | 
| Physician Professional Judgment on Procedural Success | Measurement of professional judgment (yes/no) of the treating physician. | Day 0 | 
| Procedure Duration |  | Day 0 | 
| Fluoroscopy Time |  | Day 0 | 
| Physician Professional Judgment on Adequacy of Images for Performing the EP Procedure | 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. | Day 0 | 
| Usage of Physician Controlled Dose Settings | 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. | Day 0 | 
| Serious Adverse Events |  | Day 0 if any | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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X-rays, Cardiac Electrophysiology, Image Processing, Computer-Assisted, Catheter Ablation