Back to resultsX-ray Dose Reduction in Electrophysiology
Primary Purpose
Arrhythmias, Cardiac
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Advanced image processing
Regular image processing
Sponsored by
About this trial
This is an interventional other trial for Arrhythmias, Cardiac focused on measuring X-rays, Cardiac Electrophysiology, Image Processing, Computer-Assisted, Catheter Ablation
Eligibility 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.
Sites / Locations
- Catharina Ziekenhuis
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Regular X-ray dose settings
Reduced X-ray dose settings
Arm Description
For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing
Outcomes
Primary Outcome Measures
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.
Cumulative Air Kerma (AK) Value
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)
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
Measurement of professional judgment (yes/no) of the treating physician.
Procedure Duration
Fluoroscopy Time
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.
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.
Serious Adverse Events
Full Information
NCT ID
NCT01593852
First Posted
March 27, 2012
Last Updated
March 7, 2022
Sponsor
Philips Clinical & Medical Affairs Global
Collaborators
Catharina Ziekenhuis Eindhoven
1. Study Identification
Unique Protocol Identification Number
NCT01593852
Brief Title
X-ray Dose Reduction in Electrophysiology
Official Title
X-ray Dose Reduction in Electrophysiology
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Clinical & Medical Affairs Global
Collaborators
Catharina Ziekenhuis Eindhoven
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmias, Cardiac
Keywords
X-rays, Cardiac Electrophysiology, Image Processing, Computer-Assisted, Catheter Ablation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Regular X-ray dose settings
Arm Type
Active Comparator
Arm Description
For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
Arm Title
Reduced X-ray dose settings
Arm Type
Experimental
Arm Description
For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing
Intervention Type
Radiation
Intervention Name(s)
Advanced image processing
Intervention Description
Acquisition of x-ray images with reduced X-ray dose and advanced image processing
Intervention Type
Radiation
Intervention Name(s)
Regular image processing
Intervention Description
Acquisition of x-ray images with regular X-ray dose and regular image processing
Primary Outcome Measure Information:
Title
Cumulative Dose Area Product (DAP) Value
Description
Percentage reduction of reduced X-ray dose settings (Allura Clarity) vs. regular X-ray dose settings (AlluraXper) in DAP.
Time Frame
Day 0
Title
Cumulative Air Kerma (AK) Value
Description
Percentage reduction of reducted X-ray dose settings (Allura Clarity) vs. regular X-ray dose settings (AlluraXper) in AK.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Staff Dose Measured by DoseAware and Electronic Personal Dosimeter (EPD)
Description
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)
Time Frame
Day 0
Title
Physician Professional Judgment on Procedural Success
Description
Measurement of professional judgment (yes/no) of the treating physician.
Time Frame
Day 0
Title
Procedure Duration
Time Frame
Day 0
Title
Fluoroscopy Time
Time Frame
Day 0
Title
Physician Professional Judgment on Adequacy of Images for Performing the EP Procedure
Description
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.
Time Frame
Day 0
Title
Usage of Physician Controlled Dose Settings
Description
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.
Time Frame
Day 0
Title
Serious Adverse Events
Time Frame
Day 0 if any
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lukas Dekker, MD, PhD
Organizational Affiliation
Catharina Ziekenhuis Eindhoven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catharina Ziekenhuis
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
23973946
Citation
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.
Results Reference
result
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X-ray Dose Reduction in Electrophysiology
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