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Trial record 1 of 9 for:    AURUM 8
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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.
 
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

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.

Condition or disease Intervention/treatment Phase
Atrial Flutter Device: Gold tip catheter Device: Platinum-iridium tip catheter Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 463 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AURUM 8 - Ablation of the Cavotricuspid Isthmus in Patients With Atrial Flutter Using an 8 mm Gold Alloy Tip Electrode
Study Start Date : June 2004
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Arm Intervention/treatment
Experimental: Gold tip catheter
Gold tip catheter
Device: Gold tip catheter
Radiofrquency ablation using gold tip catheter

Active Comparator: Platinum-iridium tip catheter
Platinum-iridium tip catheter
Device: Platinum-iridium tip catheter
Radiofrequency ablation using platinum-iridium tip catheter




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


Secondary Outcome Measures :
  1. Ablation Success With the First Catheter [ Time Frame: ablation procedure ]

    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.


  2. Number of Patients With Long-term Treatment Success [ Time Frame: 6 months after ablation ]
    No recurrence of atrial flutter after ablation

  3. Number of Patients With Charred Catheter Tips [ Time Frame: ablation procedure ]
    Char or coagulum formation on the catheter tip



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00326001


Locations
Show Show 28 study locations
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
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Principal Investigator: Thorsten Lewalter, Assoc. Prof. Dr. Universitätsklinikum Bonn, Medizinische Klinik and Poliklinik II, Sigmund-Freud-Strasse 25, D-53105 Bonn, Germany
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00326001    
Other Study ID Numbers: EP016
First Posted: May 16, 2006    Key Record Dates
Results First Posted: February 4, 2010
Last Update Posted: February 18, 2010
Last Verified: August 2009
Keywords provided by Biotronik SE & Co. KG:
Transvenous Catheter Ablation
Radiofrequency Catheter Ablation
Atrial flutter
Catheter Ablation
Additional relevant MeSH terms:
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Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes