Arrhythmias, Cardiac
Conditions
Keywords
X-rays, Cardiac Electrophysiology, Image Processing, Computer-Assisted, Catheter Ablation
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.
Interventions
RADIATIONAdvanced image processing
Acquisition of x-ray images with reduced X-ray dose and advanced image processing
RADIATIONRegular image processing
Acquisition of x-ray images with regular X-ray dose and regular image processing
Sponsors
Catharina Ziekenhuis Eindhoven
Philips Clinical & Medical Affairs Global
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Dose Area Product (DAP) Value | Day 0 | Percentage reduction of reduced X-ray dose settings (Allura Clarity) vs. regular X-ray dose settings (AlluraXper) in DAP. |
| Cumulative Air Kerma (AK) Value | Day 0 | Percentage reduction of reducted X-ray dose settings (Allura Clarity) vs. regular X-ray dose settings (AlluraXper) in AK. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Duration | Day 0 | — |
| Fluoroscopy Time | Day 0 | — |
| Staff Dose Measured by DoseAware and Electronic Personal Dosimeter (EPD) | Day 0 | 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) |
| Usage of Physician Controlled Dose Settings | Day 0 | 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 | Day 0 if any | — |
| Physician Professional Judgment on Adequacy of Images for Performing the EP Procedure | Day 0 | 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. |
| Physician Professional Judgment on Procedural Success | Day 0 | Measurement of professional judgment (yes/no) of the treating physician. |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 68 |
| 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 | 68 |
| Total | 136 |
Baseline characteristics
| Characteristic | Reduced X-ray Dose Settings | Regular X-ray Dose Settings | Total |
|---|---|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 14 | 65 years STANDARD_DEVIATION 9 | 61 years STANDARD_DEVIATION 12 |
| Region of Enrollment Netherlands | 68 participants | 68 participants | 136 participants |
| Sex: Female, Male Female | 18 Participants | 17 Participants | 35 Participants |
| Sex: Female, Male Male | 50 Participants | 51 Participants | 101 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 68 | 0 / 68 |
| serious Total, serious adverse events | 1 / 68 | 0 / 68 |
Outcome results
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.
Time frame: Day 0
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Reduced X-ray Dose Settings (Allura Clarity) | Cumulative Air Kerma (AK) Value | 75 mGy |
| Regular X-ray Dose Settings (AlluraXper) | Cumulative Air Kerma (AK) Value | 126 mGy |
p-value: <0.0001Wilcoxon (Mann-Whitney)
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.
Time frame: Day 0
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Reduced X-ray Dose Settings (Allura Clarity) | Cumulative Dose Area Product (DAP) Value | 8.8 Gy*cm^2 |
| Regular X-ray Dose Settings (AlluraXper) | Cumulative Dose Area Product (DAP) Value | 15.3 Gy*cm^2 |
p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Fluoroscopy Time
Time frame: Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reduced X-ray Dose Settings (Allura Clarity) | Fluoroscopy Time | 24 minutes | Standard Deviation 13 |
| Regular X-ray Dose Settings (AlluraXper) | Fluoroscopy Time | 26 minutes | Standard Deviation 13 |
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.
Time frame: Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reduced X-ray Dose Settings (Allura Clarity) | Physician Professional Judgment on Adequacy of Images for Performing the EP Procedure | 83 Number of exposure frames | Standard Deviation 89 |
| Regular X-ray Dose Settings (AlluraXper) | Physician Professional Judgment on Adequacy of Images for Performing the EP Procedure | 61 Number of exposure frames | Standard Deviation 66 |
Secondary
Physician Professional Judgment on Procedural Success
Measurement of professional judgment (yes/no) of the treating physician.
Time frame: Day 0
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reduced X-ray Dose Settings (Allura Clarity) | Physician Professional Judgment on Procedural Success | 91 percentage of procedural success |
| Regular X-ray Dose Settings (AlluraXper) | Physician Professional Judgment on Procedural Success | 91 percentage of procedural success |
Secondary
Procedure Duration
Time frame: Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reduced X-ray Dose Settings (Allura Clarity) | Procedure Duration | 160 minutes | Standard Deviation 58 |
| Regular X-ray Dose Settings (AlluraXper) | Procedure Duration | 162 minutes | Standard Deviation 58 |
Secondary
Serious Adverse Events
Time frame: Day 0 if any
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reduced X-ray Dose Settings (Allura Clarity) | Serious Adverse Events | 1 participants |
| Regular X-ray Dose Settings (AlluraXper) | Serious Adverse Events | 0 participants |
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)
Time frame: Day 0
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Reduced X-ray Dose Settings (Allura Clarity) | Staff Dose Measured by DoseAware and Electronic Personal Dosimeter (EPD) | EPD operator | 3 µSv |
| Reduced X-ray Dose Settings (Allura Clarity) | Staff Dose Measured by DoseAware and Electronic Personal Dosimeter (EPD) | EPD fixed | 10 µSv |
| Regular X-ray Dose Settings (AlluraXper) | Staff Dose Measured by DoseAware and Electronic Personal Dosimeter (EPD) | EPD operator | 6 µSv |
| Regular X-ray Dose Settings (AlluraXper) | Staff Dose Measured by DoseAware and Electronic Personal Dosimeter (EPD) | EPD fixed | 19 µSv |
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.
Time frame: Day 0
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reduced X-ray Dose Settings (Allura Clarity) | Usage of Physician Controlled Dose Settings | Low | 86 percentage of total # of fluoro frames | Standard Deviation 28 |
| Reduced X-ray Dose Settings (Allura Clarity) | Usage of Physician Controlled Dose Settings | Medium | 2 percentage of total # of fluoro frames | Standard Deviation 8 |
| Reduced X-ray Dose Settings (Allura Clarity) | Usage of Physician Controlled Dose Settings | High | 12 percentage of total # of fluoro frames | Standard Deviation 24 |
| Regular X-ray Dose Settings (AlluraXper) | Usage of Physician Controlled Dose Settings | Low | 88 percentage of total # of fluoro frames | Standard Deviation 20 |
| Regular X-ray Dose Settings (AlluraXper) | Usage of Physician Controlled Dose Settings | Medium | 2 percentage of total # of fluoro frames | Standard Deviation 9 |
| Regular X-ray Dose Settings (AlluraXper) | Usage of Physician Controlled Dose Settings | High | 9 percentage of total # of fluoro frames | Standard Deviation 19 |