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Isthmus Ablation With Gold Electrode for Treatment of Atrial Flutter (AURUM 8)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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

Tracking Information
First Submitted Date  ICMJE May 12, 2006
First Posted Date  ICMJE May 16, 2006
Results First Submitted Date  ICMJE May 13, 2009
Results First Posted Date  ICMJE February 4, 2010
Last Update Posted Date February 18, 2010
Study Start Date  ICMJE June 2004
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2010)
Duration of Energy Application [ Time Frame: ablation procedure ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 12, 2006)
Duration of Energy Application
Change History Complete list of historical versions of study NCT00326001 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2010)
  • Ablation Success With the First Catheter [ Time Frame: ablation procedure ]
  • Number of Patients With Long-term Treatment Success [ Time Frame: 6 months after ablation ]
  • Number of Patients With Charred Catheter Tips [ Time Frame: ablation procedure ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2006)
  • Success rate
  • Acute and long-term treatment success
  • Comparison of ablation parameters
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Isthmus Ablation With Gold Electrode for Treatment of Atrial Flutter (AURUM 8)
Official Title  ICMJE AURUM 8 - Ablation of the Cavotricuspid Isthmus in Patients With Atrial Flutter Using an 8 mm Gold Alloy Tip Electrode
Brief Summary The purpose of this study is to demonstrate the advantage of using a gold alloy tip electrode over a platinum/iridium alloy tip electrode in ablation of the cavotricuspid isthmus in patients with atrial flutter.
Detailed Description

Transvenous catheter ablation has become the therapy of choice for patients with recurring, isthmus-dependent right atrial flutter. Achieving bidirectional conduction block in the cavotricuspid isthmus is decisive for both acute and long-term therapy success and essentially depends on the selected ablation method and the lesion size. By using an 8 mm tip electrode instead of a conventional 4 mm electrode, deeper lesions can be made, thus significantly reducing the required number of energy applications for achieving a bidirectional conduction block. Experimental studies have proven that using an ablation electrode made of gold alloy allows the creation of deeper lesions than with conventional platinum-iridium electrodes. Due to the greater heat conductivity of the gold alloy as opposed to platinum-iridium, the cooling of the ablation electrode is improved and more electric energy can be transmitted to the tissue at identical temperatures.

The combination of both technologies in the form of an 8 mm-long gold electrode anticipates that the lesion depth required for an isthmus block can be achieved more quickly in comparison to the platinum-iridium electrode.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atrial Flutter
Intervention  ICMJE
  • Device: Gold tip catheter
    Radiofrquency ablation using gold tip catheter
  • Device: Platinum-iridium tip catheter
    Radiofrequency ablation using platinum-iridium tip catheter
Study Arms  ICMJE
  • Experimental: Gold tip catheter
    Gold tip catheter
    Intervention: Device: Gold tip catheter
  • Active Comparator: Platinum-iridium tip catheter
    Platinum-iridium tip catheter
    Intervention: Device: Platinum-iridium tip catheter
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 12, 2008)
Original Enrollment  ICMJE
 (submitted: May 12, 2006)
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • At least one electrocardiogram (ECG)-documented (can be older than 3 months), symptomatic, typical atrial flutter episode with either negative, sawtooth-shaped P-waves in leads II, III, and augmented voltage foot (aVF), or positive P-waves in leads II, III, and aVF
  • At least one persistent, typical atrial flutter episode of over 2 hours that has been documented in the history in the patient file and/or ECG
  • Signed informed consent form

Exclusion Criteria:

  • Patient has recently undergone isthmus ablation
  • Acute coronary syndrome or myocardial infarction within the last 3 months
  • Acute reversible causes for atrial flutter (e.g. acute myocarditis)
  • Severe cardiac valvular defects
  • Tricuspid valve replacement
  • Atrial septum defect
  • Cardiovascular surgery scheduled within the next 6 months
  • Unstable medication in the last 7 days before study inclusion
  • New York Heart Association (NYHA) class IV
  • Women who are breastfeeding
  • Pregnancy
  • Abuse of drugs or alcohol
  • Patient is unable to participate in follow-up examinations
  • The patient has only partial legal competence
  • Participation in another clinical study
  • The ablation procedure presents an above average risk to the patient as compared to the normal patient group (must be noted by the physician on the appropriate form).
  • Right atrial thrombus

Late Exclusion Criteria:

  • Patient included by accident
  • Premature termination of the ablation procedure
  • Atrial flutter not dependent on the posterior isthmus
  • No conduction at the posterior isthmus before ablation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic,   Germany,   Hungary
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00326001
Other Study ID Numbers  ICMJE EP016
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Biotronik SE & Co. KG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thorsten Lewalter, Assoc. Prof. Dr. Universitätsklinikum Bonn, Medizinische Klinik and Poliklinik II, Sigmund-Freud-Strasse 25, D-53105 Bonn, Germany
PRS Account Biotronik SE & Co. KG
Verification Date August 2009

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