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
  Purpose

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).


Condition Intervention
Arrhythmias, Cardiac
Radiation: Advanced image processing
Radiation: Regular image processing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: X-ray Dose Reduction in Electrophysiology

Resource links provided by NLM:


Further study details as provided by Philips Healthcare:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 136
Study Start Date: April 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01593852

Locations
Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands, 5623 EJ
Sponsors and Collaborators
Philips Healthcare
Catharina Ziekenhuis Eindhoven
Investigators
Principal Investigator: Lukas Dekker, MD, PhD Catharina Ziekenhuis Eindhoven
  More Information

Publications:
Responsible Party: Philips Healthcare
ClinicalTrials.gov Identifier: NCT01593852     History of Changes
Other Study ID Numbers: NL39479.060.012
Study First Received: March 27, 2012
Results First Received: December 9, 2013
Last Updated: February 17, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Philips Healthcare:
X-rays
Cardiac Electrophysiology
Image Processing, Computer-Assisted
Catheter Ablation

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014