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Trial record 1 of 7 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
Sponsor:
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
Enrollment 463
Recruitment Details 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 No exclusion before assignment
Arm/Group Title Gold Tip Catheter Pt-Ir Tip Catheter
Hide Arm/Group Description Patients allocated to be ablated by 8-mm gold tip catheter Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
Period Title: Overall Study
Started 236 227
Completed 229 219
Not Completed 7 8
Reason Not Completed
Adverse Event             4             5
Physician Decision             3             3
Arm/Group Title Gold Tip Catheter Pt-Ir Tip Catheter Total
Hide Arm/Group Description Patients allocated to be ablated by 8-mm gold tip catheter Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter Total of all reporting groups
Overall Number of Baseline Participants 236 227 463
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 236 participants 227 participants 463 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
97
  41.1%
92
  40.5%
189
  40.8%
>=65 years
139
  58.9%
135
  59.5%
274
  59.2%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 236 participants 227 participants 463 participants
66  (10) 66  (11) 66  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 236 participants 227 participants 463 participants
Female
45
  19.1%
35
  15.4%
80
  17.3%
Male
191
  80.9%
192
  84.6%
383
  82.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 236 participants 227 participants 463 participants
Czech Republic 9 8 17
Germany 227 219 446
1.Primary Outcome
Title Duration of Energy Application
Hide Description Cumulative amount of time current is flowing through the catheter tip. The current (in the radiofrequency range) is applied to ablate the cavotricuspid isthmus in the right atrium.
Time Frame ablation procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol
Arm/Group Title Gold Tip Catheter Pt-Ir Tip Catheter
Hide Arm/Group Description:
Patients allocated to be ablated by 8-mm gold tip catheter
Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
Overall Number of Participants Analyzed 229 219
Mean (Standard Deviation)
Unit of Measure: minute
10.2  (6.9) 10.9  (6.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gold Tip Catheter, Pt-Ir Tip Catheter
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments P-value not adjusted for multiple comparisons
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Ablation Success With the First Catheter
Hide Description

Delivery of radiofrequency current was repeated until a cavotricuspid isthmus (CTI) conduction block was detected. The final bidirectional CTI block test (well documented in the literature) was performed 20 minutes after the last radiofrequency current delivery to assess ablation success (Y/N).

Positive final bidirectional cavotricuspid isthmus condution block test means "ablation successful".

Negative final bidirectional cavotricuspid isthmus condution block test means "ablation unsuccessful"; ablation should be continued until success or terminated and classified as unsuccess.

Time Frame ablation procedure
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Gold Tip Catheter Pt-Ir Tip Catheter
Hide Arm/Group Description:
Patients allocated to be ablated by 8-mm gold tip catheter
Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
Overall Number of Participants Analyzed 229 219
Measure Type: Number
Unit of Measure: Patients
216 195
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gold Tip Catheter, Pt-Ir Tip Catheter
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.042
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Number of Patients With Long-term Treatment Success
Hide Description No recurrence of atrial flutter after ablation
Time Frame 6 months after ablation
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Gold Tip Catheter Pt-Ir Tip Catheter
Hide Arm/Group Description:
Patients allocated to be ablated by 8-mm gold tip catheter
Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
Overall Number of Participants Analyzed 229 219
Measure Type: Number
Unit of Measure: Patients
225 213
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gold Tip Catheter, Pt-Ir Tip Catheter
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Number of Patients With Charred Catheter Tips
Hide Description Char or coagulum formation on the catheter tip
Time Frame ablation procedure
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Gold Tip Catheter Pt-Ir Tip Catheter
Hide Arm/Group Description:
Patients allocated to be ablated by 8-mm gold tip catheter
Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
Overall Number of Participants Analyzed 229 219
Measure Type: Number
Unit of Measure: Patients
11 83
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gold Tip Catheter, Pt-Ir Tip Catheter
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gold Tip Catheter Pt-Ir Tip Catheter
Hide Arm/Group Description Patients allocated to be ablated by 8-mm gold tip catheter Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
All-Cause Mortality
Gold Tip Catheter Pt-Ir Tip Catheter
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Gold Tip Catheter Pt-Ir Tip Catheter
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/229 (8.73%)      12/219 (5.48%)    
General disorders     
Death * [1]  2/229 (0.87%)  2 1/219 (0.46%)  1
Hospitalization * [2]  18/229 (7.86%)  18 12/219 (5.48%)  12
*
Indicates events were collected by non-systematic assessment
[1]
Death for any cause
[2]
Hospitalization for any cause
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Gold Tip Catheter Pt-Ir Tip Catheter
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/229 (0.00%)      0/219 (0.00%)    
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
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