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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)

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ClinicalTrials.gov Identifier: NCT00326001
Recruitment Status : Completed
First Posted : May 16, 2006
Results First Posted : February 4, 2010
Last Update Posted : February 18, 2010
Information provided by:
Biotronik SE & Co. KG

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Atrial Flutter
Interventions: Device: Gold tip catheter
Device: Platinum-iridium tip catheter

  Participant Flow

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
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 
Adverse Event                4                5 
Physician Decision                3                3 

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
 236   227   463 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   97   92   189 
>=65 years   139   135   274 
[Units: Years]
Mean (Standard Deviation)
 66  (10)   66  (11)   66  (11) 
[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

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

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
No text entered.

  More Information

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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00326001     History of Changes
Other Study ID Numbers: EP016
First Submitted: May 12, 2006
First Posted: May 16, 2006
Results First Submitted: May 13, 2009
Results First Posted: February 4, 2010
Last Update Posted: February 18, 2010