Clinical trial NCT01593852: X-ray Dose Reduction in Electrophysiology
Official title: X-ray Dose Reduction in Electrophysiology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arrhythmias, Cardiac
Keywords: X-rays
Cardiac Electrophysiology
Image Processing, Computer-Assisted
Catheter Ablation
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
Collaborators: name: Catharina Ziekenhuis Eindhoven
First posted: 2012-05-08
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Cumulative Dose Area Product (DAP) Value
timeFrame: Day 0
measure: Cumulative Air Kerma (AK) Value
timeFrame: Day 0
Secondary outcomes:
measure: Staff Dose Measured by DoseAware and Electronic Personal Dosimeter (EPD)
timeFrame: Day 0
measure: Physician Professional Judgment on Procedural Success
timeFrame: Day 0
measure: Procedure Duration
timeFrame: Day 0
measure: Fluoroscopy Time
timeFrame: Day 0
measure: Physician Professional Judgment on Adequacy of Images for Performing the EP Procedure
timeFrame: Day 0
measure: Usage of Physician Controlled Dose Settings
timeFrame: Day 0
measure: Serious Adverse Events
timeFrame: Day 0 if any
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
Study officials:
affiliation: Catharina Ziekenhuis Eindhoven
name: Lukas Dekker, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.