X-ray Dose Reduction in Electrophysiology

This study has been completed.

Sponsor:

Collaborator:

Catharina Ziekenhuis Eindhoven

Information provided by (Responsible Party):

Philips Healthcare

ClinicalTrials.gov Identifier:

NCT01593852

First received: March 27, 2012

Last updated: January 30, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 27, 2012

Last Updated Date

January 30, 2013

Start Date ^ICMJE

April 2012

Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01593852 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

X-ray Dose Reduction in Electrophysiology

Official Title ^ICMJE

X-ray Dose Reduction in Electrophysiology

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label

Condition ^ICMJE

Arrhythmias, Cardiac

Intervention ^ICMJE

Radiation: Advanced image processing

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

Study Arm (s)

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

Intervention: Radiation: Advanced image processing

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

136

Completion Date

January 2013

Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT01593852

Other Study ID Numbers ^ICMJE

NL39479.060.012

Has Data Monitoring Committee

Responsible Party

Philips Healthcare

Study Sponsor ^ICMJE

Philips Healthcare

Collaborators ^ICMJE

Catharina Ziekenhuis Eindhoven

Investigators ^ICMJE

Principal Investigator:

Lukas Dekker, MD, PhD

Catharina Ziekenhuis Eindhoven

Information Provided By

Philips Healthcare

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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