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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: February 17, 2014
Last verified: February 2014
Results First Received: December 9, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label
Condition: Arrhythmias, Cardiac
Interventions: Radiation: Advanced image processing
Radiation: Regular image processing

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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

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

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

Participant Flow:   Overall Study
    Reduced X-ray Dose Settings     Regular X-ray Dose Settings  
STARTED     68     68  
COMPLETED     68     68  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

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

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
Total Total of all reporting groups

Baseline Measures
    Reduced X-ray Dose Settings     Regular X-ray Dose Settings     Total  
Number of Participants  
[units: participants]
  68     68     136  
Age  
[units: years]
Mean ± Standard Deviation
  58  ± 14     65  ± 9     61  ± 12  
Gender  
[units: participants]
     
Female     18     17     35  
Male     50     51     101  
Region of Enrollment  
[units: participants]
     
Netherlands     68     68     136  



  Outcome Measures
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1.  Primary:   Cumulative Dose Area Product (DAP) Value   [ Time Frame: Day 0 ]

2.  Primary:   Cumulative Air Kerma (AK) Value   [ Time Frame: Day 0 ]

3.  Secondary:   Staff Dose Measured by DoseAware and Electronic Personal Dosimeter (EPD)   [ Time Frame: Day 0 ]

4.  Secondary:   Physician Professional Judgment on Procedural Success   [ Time Frame: Day 0 ]

5.  Secondary:   Procedure Duration   [ Time Frame: Day 0 ]

6.  Secondary:   Fluoroscopy Time   [ Time Frame: Day 0 ]

7.  Secondary:   Physician Professional Judgment on Adequacy of Images for Performing the EP Procedure   [ Time Frame: Day 0 ]

8.  Secondary:   Usage of Physician Controlled Dose Settings   [ Time Frame: Day 0 ]

9.  Secondary:   Serious Adverse Events   [ Time Frame: Day 0 if any ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Lukas Dekker, MD, PhD
Organization: Catharina Hospital Eindhoven
phone: +31 40 239 7000
e-mail: lukas.dekker@catharina_ziekenhuis.nl


Publications of Results:

Responsible Party: Philips Healthcare
ClinicalTrials.gov Identifier: NCT01593852     History of Changes
Other Study ID Numbers: NL39479.060.012
Study First Received: March 27, 2012
Results First Received: December 9, 2013
Last Updated: February 17, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)