X-ray Dose Reduction in Electrophysiology
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 136
- Locations
- 2
- Primary Endpoint
- Cumulative Dose Area Product (DAP) Value
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Fluoroscopy Time(Day 0)
- Serious Adverse Events(Day 0 if any)
- Staff Dose Measured by DoseAware and Electronic Personal Dosimeter (EPD)(Day 0)
- Usage of Physician Controlled Dose Settings(Day 0)
- Physician Professional Judgment on Procedural Success(Day 0)
- Physician Professional Judgment on Adequacy of Images for Performing the EP Procedure(Day 0)
- Procedure Duration(Day 0)