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).

Study Overview

• Status: Completed
• Conditions: Arrhythmias, Cardiac
• Intervention / Treatment: Radiation: Regular image processing; Radiation: Advanced image processing

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 Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Eindhoven, Netherlands, 5623 EJ
    • Catharina Ziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Radiation: Regular image processing; Acquisition of x-ray images with regular X-ray dose and 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	Radiation: Advanced image processing; Acquisition of x-ray images with reduced X-ray dose and advanced image processing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Dose Area Product (DAP) Value	Percentage reduction of reduced X-ray dose settings (Allura Clarity) vs. regular X-ray dose settings (AlluraXper) in DAP.	Day 0
Cumulative Air Kerma (AK) Value	Percentage reduction of reducted X-ray dose settings (Allura Clarity) vs. regular X-ray dose settings (AlluraXper) in AK.	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Staff Dose Measured by DoseAware and Electronic Personal Dosimeter (EPD)	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)	Day 0
Physician Professional Judgment on Procedural Success	Measurement of professional judgment (yes/no) of the treating physician.	Day 0
Procedure Duration		Day 0
Fluoroscopy Time		Day 0
Physician Professional Judgment on Adequacy of Images for Performing the EP Procedure	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.	Day 0
Usage of Physician Controlled Dose Settings	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.	Day 0
Serious Adverse Events		Day 0 if any

Collaborators and Investigators

• Sponsor: Philips Clinical & Medical Affairs Global
• Collaborators: Catharina Ziekenhuis Eindhoven
• Investigators: Principal Investigator: Lukas Dekker, MD, PhD, Catharina Ziekenhuis Eindhoven

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: March 27, 2012
• First Submitted That Met QC Criteria: May 7, 2012
• First Posted (Estimate): May 8, 2012

Study Record Updates

• Last Update Posted (Actual): March 8, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Catheter Ablation; X-rays; Cardiac Electrophysiology; Image Processing, Computer-Assisted
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: NL39479.060.012