X-ray Dose Reduction in Electrophysiology

Philips

Status: Completed

Conditions: Arrhythmias, Cardiac

Treatments: Radiation: Regular image processing; Radiation: Advanced image processing

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01593852

NL39479.060.012

Details and patient eligibility

About

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).

Full 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.

Enrollment: 136 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

Regular X-ray dose settings

Active Comparator group

Description:

For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing

Treatment:

Radiation: Regular image processing

Reduced X-ray dose settings

Experimental group

Description:

For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing

Treatment:

Radiation: Advanced image processing