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| Name | Class |
|---|---|
| Catharina Ziekenhuis Eindhoven | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regular X-ray dose settings | Active Comparator | For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing |
|
| Reduced X-ray dose settings | Experimental | For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advanced image processing | Radiation | Acquisition of x-ray images with reduced X-ray dose and advanced image processing |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lukas Dekker, MD, PhD | Catharina Ziekenhuis Eindhoven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catharina Ziekenhuis | Eindhoven | 5623 EJ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23973946 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing |
| BG001 | Regular X-ray Dose Settings |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | Gy*cm^2 | Day 0 |
|
During procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reduced X-ray Dose Settings (Allura Clarity) | For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericardial tamponade | Cardiac disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lukas Dekker, MD, PhD | Catharina Hospital Eindhoven | +31 40 239 7000 | lukas.dekker@catharina_ziekenhuis.nl |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Regular image processing | Radiation | Acquisition of x-ray images with regular X-ray dose and regular image processing |
|
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 |
For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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|
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| Secondary | 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) | Posted | Median | Inter-Quartile Range | µSv | Day 0 |
|
|
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| Secondary | Physician Professional Judgment on Procedural Success | Measurement of professional judgment (yes/no) of the treating physician. | Posted | Number | percentage of procedural success | Day 0 |
|
|
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| Secondary | Procedure Duration | Posted | Mean | Standard Deviation | minutes | Day 0 |
|
|
|
| Secondary | Fluoroscopy Time | Posted | Mean | Standard Deviation | minutes | Day 0 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Number of exposure frames | Day 0 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | percentage of total # of fluoro frames | Day 0 |
|
|
|
| Secondary | Serious Adverse Events | Posted | Number | participants | Day 0 if any |
|
|
|
| Primary | Cumulative Air Kerma (AK) Value | Percentage reduction of reducted X-ray dose settings (Allura Clarity) vs. regular X-ray dose settings (AlluraXper) in AK. | Posted | Median | Inter-Quartile Range | mGy | Day 0 |
|
|
|
|
| 1 |
| 68 |
| 0 |
| 68 |
| EG001 | Regular X-ray Dose Settings (AlluraXper) | For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing | 0 | 68 | 0 | 68 |
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| High |
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