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CompletedNCT00326001Updated Feb 18, 2010Results posted

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

A Phase 4 interventional study of Gold tip catheter and Platinum-iridium tip catheter in Atrial Flutter, sponsored by Biotronik SE & Co. KG. Completed at 28 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-02-18.

Sponsored by Biotronik SE & Co. KG · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
463
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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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Conditions studied

  • Atrial Flutter

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Keywords

  • Transvenous Catheter Ablation
  • Radiofrequency Catheter Ablation
  • Atrial flutter
  • Catheter Ablation
03

In context

Atrial Flutter

213 studies on the registry are indexed under Atrial Flutter; 50 are open to participants now.

This study's enrollment of 463 is above the median of 134 across 145 interventional studies indexed under Atrial Flutter.

Browse Atrial Flutter studies →

Lead sponsor

Biotronik SE & Co. KG is the lead sponsor of 83 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
463 participants (actual)

Study arms

  • Experimental
    Gold tip catheter

    Gold tip catheter

    Device: Gold tip catheter

  • Active comparator
    Platinum-iridium tip catheter

    Platinum-iridium tip catheter

    Device: Platinum-iridium tip catheter

Interventions

  • DeviceGold tip catheter

    Radiofrquency ablation using gold tip catheter

  • DevicePlatinum-iridium tip catheter

    Radiofrequency ablation using platinum-iridium tip catheter

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What researchers measure

Primary outcomes

  1. Duration of Energy Application

    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

Secondary outcomes

  1. Ablation Success With the First Catheter

    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

  2. Number of Patients With Long-term Treatment Success

    No recurrence of atrial flutter after ablation

    Time frame: 6 months after ablation

  3. Number of Patients With Charred Catheter Tips

    Char or coagulum formation on the catheter tip

    Time frame: ablation procedure

07

Results

Posted Feb 4, 2010

Participant flow

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.

Participant flow — Overall Study
MilestoneGold Tip CatheterPt-Ir Tip Catheter
Started236227
Completed229219
Not completed78
Withdrew: Adverse event45
Withdrew: Physician decision33

Outcome measures

PrimaryDuration of Energy Application

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
Reported as:
Mean · minute
Duration of Energy Application
minuteGold Tip CatheterPt-Ir Tip Catheter
Duration of Energy Application10.2 ± 6.910.9 ± 6.9
Statistical analysis
  • Gold Tip Catheter vs Pt-Ir Tip Catheter · t-test, 2 sided · p = 0.25 (P-value not adjusted for multiple comparisons)
SecondaryAblation Success With the First Catheter

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
Reported as:
Number · Patients
Ablation Success With the First Catheter
PatientsGold Tip CatheterPt-Ir Tip Catheter
Ablation Success With the First Catheter216195
Statistical analysis
  • Gold Tip Catheter vs Pt-Ir Tip Catheter · Chi-squared · p = 0.042
SecondaryNumber of Patients With Long-term Treatment Success

No recurrence of atrial flutter after ablation

Time frame:
6 months after ablation
Reported as:
Number · Patients
Number of Patients With Long-term Treatment Success
PatientsGold Tip CatheterPt-Ir Tip Catheter
Number of Patients With Long-term Treatment Success225213
Statistical analysis
  • Gold Tip Catheter vs Pt-Ir Tip Catheter · Chi-squared · p = 0.53
SecondaryNumber of Patients With Charred Catheter Tips

Char or coagulum formation on the catheter tip

Time frame:
ablation procedure
Reported as:
Number · Patients
Number of Patients With Charred Catheter Tips
PatientsGold Tip CatheterPt-Ir Tip Catheter
Number of Patients With Charred Catheter Tips1183
Statistical analysis
  • Gold Tip Catheter vs Pt-Ir Tip Catheter · Chi-squared · p = <0.001

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Gold Tip Catheter—20/229 (8.7%)0/229 (0%)
Pt-Ir Tip Catheter—12/219 (5.5%)0/219 (0%)
Most frequent serious events
Most frequent serious events
EventGold Tip CatheterPt-Ir Tip Catheter
HospitalizationGeneral disorders18/22912/219
DeathGeneral disorders2/2291/219

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Gold Tip CatheterPt-Ir Tip CatheterTotal
<=18 years000
Between 18 and 65 years9792189
>=65 years139135274
Age Continuous
Age Continuous(years)Gold Tip CatheterPt-Ir Tip CatheterTotal
Mean66 ± 1066 ± 1166 ± 11
Sex: Female, Male
Sex: Female, Male(Participants)Gold Tip CatheterPt-Ir Tip CatheterTotal
Female453580
Male191192383
Region of Enrollment
Region of Enrollment(participants)Gold Tip CatheterPt-Ir Tip CatheterTotal
Czech Republic9817
Germany227219446
08

Study locations

28 sites
  • Institute of Clinical and Experimental Medicine
    Praha, 14021, Czech Republic
  • Universitätsklinik der RWTH Aachen
    Aachen, 52074, Germany
  • Kerckhoff Klinik
    Bad Nauheim, 61231, Germany
  • Charité Campus Mitte, Medizinische Fakultät der Humboldt Universität zu Berlin
    Berlin, 10117, Germany
  • Vivantes Klinikum Am Urban
    Berlin, 10967, Germany
  • Universitätsklinikum Charité, Campus Benjamin Franklin
    Berlin, 12200, Germany
  • Universitätsklinikum Charité, Campus Buch Franz-Volhard-Klinik
    Berlin, 13125, Germany
  • Universitätsklinikum Charité, Campus Virchow-Klinikum
    Berlin, 13353, Germany
  • Berufsgenossenschaftliche Kliniken, Bergmannsheil Universitätsklinik
    Bochum, 44789, Germany
  • Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelms-Universität Bonn
    Bonn, 53105, Germany
  • Elektrophysiologische Praxis am Zentralkrankenhaus Links Der Weser
    Bremen, 28277, Germany
  • Evangelisches Krankenhaus Düsseldorf
    Duesseldorf, 40217, Germany
  • Herzzentrum Duisburg
    Duisburg, 47137, Germany
  • Georg-August-Universität, Universitätsklinikum Göttingen
    Goettingen, 37099, Germany
  • Universitätsklinikum Hamburg-Eppendorf
    Hamburg, 20246, Germany
  • Allgemeines Krankenhaus Altona
    Hamburg, 22763, Germany
  • Medizinische Hochschule Hannover
    Hannover, 30625, Germany
  • Universitätskliniken des Saarlandes
    Homburg/Saar, 66421, Germany
  • St. Vincentius Krankenhaus/St. Marien Krankenhaus - Abteilung für Innere Medizin III
    Karlsruhe, 76137, Germany
  • Herzzentrum Leipzig GmbH
    Leipzig, 04289, Germany
  • Universitätsklinikum Mainz
    Mainz, 55131, Germany
  • Städtisches Krankenhaus München-Bogenhausen
    München, 81925, Germany
  • Universitätsklinikum Ulm
    Ulm, 89070, Germany
  • Klinikum der Stadt Villingen-Schwenningen GmbH
    Villingen-Schwenningen, 78050, Germany
  • Medizinische Universitätsklinik Würzburg
    Würzburg, 97080, Germany
  • Semmelweis Medical University - Department of Cardiology
    Budapest, 1122, Hungary
  • The Debrecen University of Medicine, Center of Medicine and Health Care Sciences, Clinical Department of Cardiology
    Debrecen, 4032, Hungary
  • The University of Pecs
    Pecs, 7624, Hungary
09

References and documents

Publications

  • Lewalter T, Bitzen A, Wurtz S, Blum R, Schlodder K, Yang A, Lickfett L, Schwab JO, Schrickel JW, Tiemann K, Linhart M, Zima E, Merkely B, Luderitz B. Gold-tip electrodes--a new "deep lesion" technology for catheter ablation? In vitro comparison of a gold alloy versus platinum-iridium tip electrode ablation catheter. J Cardiovasc Electrophysiol. 2005 Jul;16(7):770-2. doi: 10.1111/j.1540-8167.2005.40832.x. PubMed 16050836 ↗
  • Berjano EJ. Gold-tip electrodes--a new 'deep lesion' technology for catheter ablation? In vitro comparison of gold alloy versus platinum-iridium tip electrode ablation catheter. J Cardiovasc Electrophysiol. 2005 Dec;16(12):1395-6. doi: 10.1111/j.1540-8167.2005.280_2.x. No abstract available. PubMed 16403084 ↗
  • Lickfett L, Mittmann-Braun E, Weiss C, Spencker S, Jung W, Haverkamp W, Willems S, Deneke T, Kautzner J, Wiedemann M, Siebels J, Pitschner HF, Hoffmann E, Hindricks G, Zabel M, Vester E, Schwacke H, Leyen JV, Mewis C, Bauer W, Lewalter T. Differences in clinical and echocardiographic parameters between paroxysmal and persistent atrial flutter in the AURUM 8 study: targets for prevention of persistent arrhythmia? Pacing Clin Electrophysiol. 2013 Feb;36(2):194-202. doi: 10.1111/pace.12051. PubMed 23379836 ↗
  • Lewalter T, Weiss C, Spencker S, Jung W, Haverkamp W, Willems S, Deneke T, Kautzner J, Wiedemann M, Siebels J, Pitschner HF, Hoffmann E, Hindricks G, Zabel M, Vester E, Schwacke H, Mittmann-Braun E, Lickfett L, Hoffmeister S, Proff J, Mewis C, Bauer W; AURUM 8 Study Investigators. Gold vs. platinum-iridium tip catheter for cavotricuspid isthmus ablation: the AURUM 8 study. Europace. 2011 Jan;13(1):102-8. doi: 10.1093/europace/euq339. Epub 2010 Sep 28. PubMed 20876601 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00326001
Lead sponsor
Biotronik SE & Co. KG
First posted
May 16, 2006
Start date
Jun 2004
Primary completion
Mar 2008
Completion
Mar 2008
Results posted
Feb 4, 2010
Last update
Feb 18, 2010

Study contacts

Thorsten Lewalter, Assoc. Prof. Dr.
principal investigator · Universitätsklinikum Bonn, Medizinische Klinik and Poliklinik II, Sigmund-Freud-Strasse 25, D-53105 Bonn, Germany
View the source record on ClinicalTrials.gov ↗

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