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X-ray Dose Reduction in Electrophysiology

This study is currently recruiting participants.
Verified May 2012 by Philips Healthcare
Sponsor:
Collaborator:
Catharina Ziekenhuis Eindhoven
Information provided by (Responsible Party):
Philips Healthcare
ClinicalTrials.gov Identifier:
NCT01593852
First received: March 27, 2012
Last updated: May 8, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention
Arrhythmias, Cardiac
 Radiation: Advanced image processing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: X-ray Dose Reduction in Electrophysiology

Resource links provided by NLM:

MedlinePlus related topics: Arrhythmia X-Rays
U.S. FDA Resources

Further study details as provided by Philips Healthcare:

Primary Outcome Measures:
  • Cumulative dose area product (DAP) value and the cumulative Air Kerma (AK) [ Time Frame: Day 0 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Staff dose measured by DoseAware and Electronic Personal Dosimeter (EPD) [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Physician professional judgment on procedural success [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: Day 0 if any ] [ Designated as safety issue: No ]
  • Physician professional judgment on adequacy of images for performing the EP procedure [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Procedure duration [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Fluoro and exposure times [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Usage of physician controlled dose settings [ Time Frame: Day 0 ] [ Designated as safety issue: No ]

Estimated Enrollment: 136
Study Start Date: April 2012
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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
Experimental: 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
 Radiation: Advanced image processing
Acquisition of x-ray images with reduced X-ray dose and advanced image processing

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. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01593852

Contacts
Contact: Lukas Dekker, MD, PhD +31-40-2397000 lukas.dekker@catharinaziekenhuis.nl

Locations
Netherlands
Catharina Ziekenhuis Recruiting
Eindhoven, Netherlands, 5623 EJ
Contact: Lukas Dekker, MD, PhD     +31-40-2397000     lukas.dekker@catharinaziekenhuis.nl    
Sponsors and Collaborators
Philips Healthcare
Catharina Ziekenhuis Eindhoven
Investigators
Principal Investigator: Lukas Dekker, MD, PhD Catharina Ziekenhuis Eindhoven
  More Information

No publications provided

Responsible Party: Philips Healthcare
ClinicalTrials.gov Identifier: NCT01593852     History of Changes
Other Study ID Numbers: NL39479.060.012
Study First Received: March 27, 2012
Last Updated: May 8, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Philips Healthcare:
X-rays
Cardiac Electrophysiology
Image Processing, Computer-Assisted
Catheter Ablation

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 17, 2012