X-ray Dose Reduction in Electrophysiology

NCT01593852 | Completed Results

• 1 other identifier: NL39479.060.012
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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).

Conditions

Arrhythmias, Cardiac

Keywords

X-rays; Cardiac Electrophysiology; Image Processing, Computer-Assisted; Catheter Ablation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• Staff Dose Measured by DoseAware and Electronic Personal Dosimeter (EPD)

  Day 0

• Physician Professional Judgment on Procedural Success

  Day 0

• Procedure Duration

  Day 0

• Fluoroscopy Time

  Day 0

• Physician Professional Judgment on Adequacy of Images for Performing the EP Procedure

  Day 0

Study Arms (2)

Regular X-ray dose settings

ACTIVE COMPARATOR

For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing

Radiation: Regular image processing

Reduced X-ray dose settings

EXPERIMENTAL

For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing

Radiation: Advanced image processing

Interventions

Advanced image processing RADIATION

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

Reduced X-ray dose settings

Regular image processing RADIATION

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

Regular X-ray dose settings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients under 18 years of age.
• Patient who are pregnant or breast feeding.

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead
• Catharina Ziekenhuis Eindhoven: collaborator

Study Sites (1)

Catharina Ziekenhuis

Eindhoven, 5623 EJ, Netherlands

Location

Related 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 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.

  PMID: 23973946 RESULT

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Lukas Dekker, MD, PhD
• Organization: Catharina Hospital Eindhoven

lukas.dekker@catharina_ziekenhuis.nl

+31 40 239 7000

Study Officials

• Lukas Dekker, MD, PhD

  Catharina Ziekenhuis Eindhoven

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2012
• First Posted: May 8, 2012
• Study Start: April 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: March 8, 2022
• Results First Posted: January 29, 2014

Record last verified: 2022-03

Locations

NL (1)