N/A
N=136
X-ray Dose Reduction in Electrophysiology
Arrhythmias, Cardiac
Bottom Line
View on ClinicalTrials.gov: NCT01593852 ↗Enrolled (actual)
136
Serious AEs
0.7%
Results posted
Jan 2014
Primary outcome: Primary: Cumulative Dose Area Product (DAP) Value — 8.8; 15.3 Gy*cm^2 — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Advanced image processing (Radiation); Regular image processing (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Philips Clinical & Medical Affairs Global
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Dose Area Product (DAP) Value |
8.8; 15.3 | <0.0001 sig |
| PRIMARY Cumulative Air Kerma (AK) Value |
75; 126 | <0.0001 sig |
| SECONDARY Staff Dose Measured by DoseAware and Electronic Personal Dosimeter (EPD) |
3; 6; 10; 19 | — |
| SECONDARY Physician Professional Judgment on Procedural Success |
91; 91 | — |
| SECONDARY Procedure Duration |
160; 162 | — |
| SECONDARY Fluoroscopy Time |
24; 26 | — |
| SECONDARY Physician Professional Judgment on Adequacy of Images for Performing the EP Procedure |
83; 61 | — |
| SECONDARY Usage of Physician Controlled Dose Settings |
86; 88; 2; 2; 12; 9 | — |
| SECONDARY Serious Adverse Events |
1; 0 | — |
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).
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.
Data sourced from ClinicalTrials.gov (NCT01593852). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.