X-ray Dose Reduction in Electrophysiology

NCT ID: NCT01593852

Last Updated: 2022-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-01-31

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.

Conditions

Arrhythmias, Cardiac

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Regular image processing

Intervention Type: RADIATION

Acquisition of x-ray images with regular X-ray dose and regular image processing

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

Group Type: EXPERIMENTAL

Advanced image processing

Intervention Type: RADIATION

Acquisition of x-ray images with reduced X-ray dose and advanced image processing

Interventions

Advanced image processing

Acquisition of x-ray images with reduced X-ray dose and advanced image processing

Intervention Type: RADIATION

Regular image processing

Acquisition of x-ray images with regular X-ray dose and regular image processing

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role: collaborator

Philips Clinical & Medical Affairs Global

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lukas Dekker, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Catharina Ziekenhuis Eindhoven

Locations

Catharina Ziekenhuis

Eindhoven, , Netherlands

Countries

Netherlands

References

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.

Reference Type: RESULT

PMID: 23973946 (View on PubMed)

Other Identifiers

NL39479.060.012

Identifier Type: -

Identifier Source: org_study_id