X-ray Dose Reduction in Electrophysiology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Cumulative Dose Area Product (DAP) Value
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients under 18 years of age.
- •Patient who are pregnant or breast feeding.
结局指标
主要结局
Cumulative Dose Area Product (DAP) Value
时间窗: 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
时间窗: Day 0
Percentage reduction of reducted X-ray dose settings (Allura Clarity) vs. regular X-ray dose settings (AlluraXper) in AK.
次要结局
- 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)