Trial Outcomes & Findings for X-ray Dose Reduction in Electrophysiology (NCT NCT01593852)
NCT ID: NCT01593852
Last Updated: 2022-03-08
Results Overview
Percentage reduction of reduced X-ray dose settings (Allura Clarity) vs. regular X-ray dose settings (AlluraXper) in DAP.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
136 participants
Primary outcome timeframe
Day 0
Results posted on
2022-03-08
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
68
|
|
Overall Study
COMPLETED
|
68
|
68
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
X-ray Dose Reduction in Electrophysiology
Baseline characteristics by cohort
| Measure |
Reduced X-ray Dose Settings
n=68 Participants
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
|
Regular X-ray Dose Settings
n=68 Participants
For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 14 • n=5 Participants
|
65 years
STANDARD_DEVIATION 9 • n=7 Participants
|
61 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
68 participants
n=5 Participants
|
68 participants
n=7 Participants
|
136 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0Percentage reduction of reduced X-ray dose settings (Allura Clarity) vs. regular X-ray dose settings (AlluraXper) in DAP.
Outcome measures
| Measure |
Reduced X-ray Dose Settings (Allura Clarity)
n=68 Participants
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
|
Regular X-ray Dose Settings (AlluraXper)
n=68 Participants
For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
|
|---|---|---|
|
Cumulative Dose Area Product (DAP) Value
|
8.8 Gy*cm^2
Interval 4.62 to 12.8
|
15.3 Gy*cm^2
Interval 9.14 to 25.53
|
PRIMARY outcome
Timeframe: Day 0Percentage reduction of reducted X-ray dose settings (Allura Clarity) vs. regular X-ray dose settings (AlluraXper) in AK.
Outcome measures
| Measure |
Reduced X-ray Dose Settings (Allura Clarity)
n=68 Participants
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
|
Regular X-ray Dose Settings (AlluraXper)
n=68 Participants
For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
|
|---|---|---|
|
Cumulative Air Kerma (AK) Value
|
75 mGy
Interval 42.85 to 122.73
|
126 mGy
Interval 85.79 to 226.4
|
SECONDARY outcome
Timeframe: Day 0Staff 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)
Outcome measures
| Measure |
Reduced X-ray Dose Settings (Allura Clarity)
n=68 Participants
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
|
Regular X-ray Dose Settings (AlluraXper)
n=68 Participants
For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
|
|---|---|---|
|
Staff Dose Measured by DoseAware and Electronic Personal Dosimeter (EPD)
EPD operator
|
3 µSv
Interval 1.0 to 6.3
|
6 µSv
Interval 3.3 to 10.0
|
|
Staff Dose Measured by DoseAware and Electronic Personal Dosimeter (EPD)
EPD fixed
|
10 µSv
Interval 5.8 to 18.0
|
19 µSv
Interval 9.0 to 38.5
|
SECONDARY outcome
Timeframe: Day 0Measurement of professional judgment (yes/no) of the treating physician.
Outcome measures
| Measure |
Reduced X-ray Dose Settings (Allura Clarity)
n=68 Participants
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
|
Regular X-ray Dose Settings (AlluraXper)
n=68 Participants
For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
|
|---|---|---|
|
Physician Professional Judgment on Procedural Success
|
91 percentage of procedural success
|
91 percentage of procedural success
|
SECONDARY outcome
Timeframe: Day 0Outcome measures
| Measure |
Reduced X-ray Dose Settings (Allura Clarity)
n=68 Participants
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
|
Regular X-ray Dose Settings (AlluraXper)
n=68 Participants
For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
|
|---|---|---|
|
Procedure Duration
|
160 minutes
Standard Deviation 58
|
162 minutes
Standard Deviation 58
|
SECONDARY outcome
Timeframe: Day 0Outcome measures
| Measure |
Reduced X-ray Dose Settings (Allura Clarity)
n=68 Participants
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
|
Regular X-ray Dose Settings (AlluraXper)
n=68 Participants
For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
|
|---|---|---|
|
Fluoroscopy Time
|
24 minutes
Standard Deviation 13
|
26 minutes
Standard Deviation 13
|
SECONDARY outcome
Timeframe: Day 0If 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.
Outcome measures
| Measure |
Reduced X-ray Dose Settings (Allura Clarity)
n=68 Participants
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
|
Regular X-ray Dose Settings (AlluraXper)
n=68 Participants
For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
|
|---|---|---|
|
Physician Professional Judgment on Adequacy of Images for Performing the EP Procedure
|
83 Number of exposure frames
Standard Deviation 89
|
61 Number of exposure frames
Standard Deviation 66
|
SECONDARY outcome
Timeframe: Day 0In 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.
Outcome measures
| Measure |
Reduced X-ray Dose Settings (Allura Clarity)
n=68 Participants
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
|
Regular X-ray Dose Settings (AlluraXper)
n=68 Participants
For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
|
|---|---|---|
|
Usage of Physician Controlled Dose Settings
Low
|
86 percentage of total # of fluoro frames
Standard Deviation 28
|
88 percentage of total # of fluoro frames
Standard Deviation 20
|
|
Usage of Physician Controlled Dose Settings
Medium
|
2 percentage of total # of fluoro frames
Standard Deviation 8
|
2 percentage of total # of fluoro frames
Standard Deviation 9
|
|
Usage of Physician Controlled Dose Settings
High
|
12 percentage of total # of fluoro frames
Standard Deviation 24
|
9 percentage of total # of fluoro frames
Standard Deviation 19
|
SECONDARY outcome
Timeframe: Day 0 if anyOutcome measures
| Measure |
Reduced X-ray Dose Settings (Allura Clarity)
n=68 Participants
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
|
Regular X-ray Dose Settings (AlluraXper)
n=68 Participants
For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
|
|---|---|---|
|
Serious Adverse Events
|
1 participants
|
0 participants
|
Adverse Events
Reduced X-ray Dose Settings (Allura Clarity)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Regular X-ray Dose Settings (AlluraXper)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Reduced X-ray Dose Settings (Allura Clarity)
n=68 participants at risk
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
|
Regular X-ray Dose Settings (AlluraXper)
n=68 participants at risk
For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
|
|---|---|---|
|
Cardiac disorders
Pericardial tamponade
|
1.5%
1/68 • Number of events 1 • During procedure
|
0.00%
0/68 • During procedure
|
Other adverse events
Adverse event data not reported
Additional Information
Lukas Dekker, MD, PhD
Catharina Hospital Eindhoven
Phone: +31 40 239 7000
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place