X-ray Dose Reduction in Electrophysiology

Arrhythmias, Cardiac Clinical Trial

Official title:

X-ray Dose Reduction in Electrophysiology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01593852
• Other study ID #: NL39479.060.012
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: January 2013

Study information

• Verified date: March 2022
• Source: Philips Clinical & Medical Affairs Global
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac

Intervention

Radiation:
• Advanced image processing
Acquisition of x-ray images with reduced X-ray dose and advanced image processing
• Regular image processing
Acquisition of x-ray images with regular X-ray dose and regular image processing

Locations

Country	Name	City	State
Netherlands	Catharina Ziekenhuis	Eindhoven

Sponsors (2)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global	Catharina Ziekenhuis Eindhoven

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Day 0
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.	Day 0
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)	Day 0
Secondary	Physician Professional Judgment on Procedural Success	Measurement of professional judgment (yes/no) of the treating physician.	Day 0
Secondary	Procedure Duration		Day 0
Secondary	Fluoroscopy Time		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.	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.	Day 0
Secondary	Serious Adverse Events		Day 0 if any