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Completed

NCT Number: NCT01593852

X-ray Dose Reduction in Electrophysiology

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).

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Key information

Conditions

Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catharina Ziekenhuis

Eindhoven, 5623 EJ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Advanced image processing

Radiation

Acquisition of x-ray images with reduced X-ray dose and advanced image processing

Regular image processing

Radiation

Acquisition of x-ray images with regular X-ray dose and regular image processing

Primary outcomes

  1. 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.

  2. 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

  1. 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)

  2. Physician Professional Judgment on Procedural Success

    Time frame: Day 0

    Measurement of professional judgment (yes/no) of the treating physician.

  3. Procedure Duration

    Time frame: Day 0

  4. Fluoroscopy Time

    Time frame: Day 0

  5. 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.

  6. 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.

  7. Serious Adverse Events

    Time frame: Day 0 if any

Sponsors and collaborators

Lead sponsor

Philips Clinical & Medical Affairs Global

Industry

Collaborators

  • Catharina Ziekenhuis Eindhoven

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 8, 2012
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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