X-ray Dose Reduction in Electrophysiology

This study has been completed.
Sponsor:
Collaborator:
Catharina Ziekenhuis Eindhoven
Information provided by (Responsible Party):
Philips Healthcare
ClinicalTrials.gov Identifier:
NCT01593852
First received: March 27, 2012
Last updated: February 17, 2014
Last verified: February 2014

March 27, 2012
February 17, 2014
April 2012
January 2013   (final data collection date for primary outcome measure)
  • Cumulative Dose Area Product (DAP) Value [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Percentage reduction of reducted X-ray dose settings (Allura Clarity) vs. regular X-ray dose settings (AlluraXper) in AK.
Cumulative dose area product (DAP) value and the cumulative Air Kerma (AK) [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01593852 on ClinicalTrials.gov Archive Site
  • Staff Dose Measured by DoseAware and Electronic Personal Dosimeter (EPD) [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    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)
  • Physician Professional Judgment on Procedural Success [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Measurement of professional judgment (yes/no) of the treating physician.
  • Procedure Duration [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Fluoroscopy Time [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Physician Professional Judgment on Adequacy of Images for Performing the EP Procedure [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    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.
  • Usage of Physician Controlled Dose Settings [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    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.
  • Serious Adverse Events [ Time Frame: Day 0 if any ] [ Designated as safety issue: No ]
  • Staff dose measured by DoseAware and Electronic Personal Dosimeter (EPD) [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Physician professional judgment on procedural success [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: Day 0 if any ] [ Designated as safety issue: No ]
  • Physician professional judgment on adequacy of images for performing the EP procedure [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Procedure duration [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Fluoro and exposure times [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Usage of physician controlled dose settings [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
X-ray Dose Reduction in Electrophysiology
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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Arrhythmias, Cardiac
  • Radiation: Advanced image processing
    Acquisition of x-ray images with reduced X-ray dose and advanced image processing
  • Radiation: Regular image processing
    Acquisition of x-ray images with regular X-ray dose and regular image processing
  • Active Comparator: Regular X-ray dose settings
    For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
    Intervention: Radiation: Regular image processing
  • Experimental: Reduced X-ray dose settings
    For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing
    Intervention: Radiation: Advanced image processing
Dekker LR, van der Voort PH, Simmers TA, Verbeek XA, Bullens RW, Veer MV, Brands PJ, Meijer A. New image processing and noise reduction technology allows reduction of radiation exposure in complex electrophysiologic interventions while maintaining optimal image quality: a randomized clinical trial. Heart Rhythm. 2013 Nov;10(11):1678-82. doi: 10.1016/j.hrthm.2013.08.018. Epub 2013 Aug 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
136
January 2013
January 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01593852
NL39479.060.012
No
Philips Healthcare
Philips Healthcare
Catharina Ziekenhuis Eindhoven
Principal Investigator: Lukas Dekker, MD, PhD Catharina Ziekenhuis Eindhoven
Philips Healthcare
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP