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Trial record 1 of 4 for:    AURUM 8
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Isthmus Ablation With Gold Electrode for Treatment of Atrial Flutter (AURUM 8)

This study has been completed.
Sponsor:
Information provided by:
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT00326001
First received: May 12, 2006
Last updated: February 3, 2010
Last verified: August 2009
Results First Received: May 13, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Atrial Flutter
Interventions: Device: Gold tip catheter
Device: Platinum-iridium tip catheter

  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
A total of 463 patients were enrolled in the AURUM 8 study from June 2004 to March 2007 in 19 clinical centers in Germany and the Czech Republic.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No exclusion before assignment

Reporting Groups
  Description
Gold Tip Catheter Patients allocated to be ablated by 8-mm gold tip catheter
Pt-Ir Tip Catheter Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter

Participant Flow:   Overall Study
    Gold Tip Catheter     Pt-Ir Tip Catheter  
STARTED     236     227  
COMPLETED     229     219  
NOT COMPLETED     7     8  
Adverse Event                 4                 5  
Physician Decision                 3                 3  



  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
Gold Tip Catheter Patients allocated to be ablated by 8-mm gold tip catheter
Pt-Ir Tip Catheter Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
Total Total of all reporting groups

Baseline Measures
    Gold Tip Catheter     Pt-Ir Tip Catheter     Total  
Number of Participants  
[units: participants]
  236     227     463  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     97     92     189  
>=65 years     139     135     274  
Age  
[units: years]
Mean ± Standard Deviation
  66  ± 10     66  ± 11     66  ± 11  
Gender  
[units: participants]
     
Female     45     35     80  
Male     191     192     383  
Region of Enrollment  
[units: participants]
     
Czech Republic     9     8     17  
Germany     227     219     446  



  Outcome Measures
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1.  Primary:   Duration of Energy Application   [ Time Frame: ablation procedure ]

2.  Secondary:   Ablation Success With the First Catheter   [ Time Frame: ablation procedure ]

3.  Secondary:   Number of Patients With Long-term Treatment Success   [ Time Frame: 6 months after ablation ]

4.  Secondary:   Number of Patients With Charred Catheter Tips   [ Time Frame: ablation procedure ]


  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: Dejan Danilovic
Organization: Biotronik GmbH&Co. KG, Berlin, Germany
phone: +49 9131 8924 7832
e-mail: dejan.danilovic@biotronik.com


Publications:
Publications automatically indexed to this study:

ClinicalTrials.gov Identifier: NCT00326001     History of Changes
Other Study ID Numbers: EP016
Study First Received: May 12, 2006
Results First Received: May 13, 2009
Last Updated: February 3, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices