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Atrial FlutterPhase 4NCT00326001

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

A Phase 4 study testing Gold tip catheter and Platinum-iridium tip catheter in people with Atrial Flutter, run by Biotronik SE & Co. KG at 28 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Flutter
What is being tested?
Gold tip catheter and Platinum-iridium tip catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
463 participants
Where
28 sitesin 3 countries
Study dates
Jun 2004to Mar 2008
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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

Trial locations and contacts

28 sites in 3 countries.

28 sites in 3 countries

Germany24 sites

  • Universitätsklinik der RWTH Aachen

    Aachen, 52074

  • Kerckhoff Klinik

    Bad Nauheim, 61231

  • Charité Campus Mitte, Medizinische Fakultät der Humboldt Universität zu Berlin

    Berlin, 10117

  • Vivantes Klinikum Am Urban

    Berlin, 10967

  • Universitätsklinikum Charité, Campus Benjamin Franklin

    Berlin, 12200

  • Universitätsklinikum Charité, Campus Buch Franz-Volhard-Klinik

    Berlin, 13125

  • Universitätsklinikum Charité, Campus Virchow-Klinikum

    Berlin, 13353

  • Berufsgenossenschaftliche Kliniken, Bergmannsheil Universitätsklinik

    Bochum, 44789

  • Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelms-Universität Bonn

    Bonn, 53105

  • Elektrophysiologische Praxis am Zentralkrankenhaus Links Der Weser

    Bremen, 28277

  • Herzzentrum Duisburg

    Duisburg, 47137

  • Evangelisches Krankenhaus Düsseldorf

    Düsseldorf, 40217

  • Georg-August-Universität, Universitätsklinikum Göttingen

    Göttingen, 37099

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Allgemeines Krankenhaus Altona

    Hamburg, 22763

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitätskliniken des Saarlandes

    Homburg/Saar, 66421

  • St. Vincentius Krankenhaus/St. Marien Krankenhaus - Abteilung für Innere Medizin III

    Karlsruhe, 76137

  • Herzzentrum Leipzig GmbH

    Leipzig, 04289

  • Universitätsklinikum Mainz

    Mainz, 55131

  • Städtisches Krankenhaus München-Bogenhausen

    München, 81925

  • Universitätsklinikum Ulm

    Ulm, 89070

  • Klinikum der Stadt Villingen-Schwenningen GmbH

    Villingen-Schwenningen, 78050

  • Medizinische Universitätsklinik Würzburg

    Würzburg, 97080

Other trials in Germany

Hungary3 sites

  • Semmelweis Medical University - Department of Cardiology

    Budapest, 1122

  • The Debrecen University of Medicine, Center of Medicine and Health Care Sciences, Clinical Department of Cardiology

    Debrecen, 4032

  • The University of Pecs

    Pécs, 7624

Other trials in Hungary

Czechia1 site

  • Institute of Clinical and Experimental Medicine

    Prague, 14021

Other trials in Czechia

About this study

Official title: AURUM 8 - Ablation of the Cavotricuspid Isthmus in Patients With Atrial Flutter Using an 8 mm Gold Alloy Tip Electrode

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.

Conditions
Atrial Flutter
Being tested
Gold tip catheter, Platinum-iridium tip catheter
Keywords
Transvenous Catheter Ablation, Radiofrequency Catheter Ablation, Atrial flutter, Catheter Ablation
Medical subject headings
Atrial Flutter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gold tip catheterDevice

    Radiofrquency ablation using gold tip catheter

  • Platinum-iridium tip catheterDevice

    Radiofrequency ablation using platinum-iridium tip catheter

Study groups in NCT00326001
Study groupRoleWhat they receive
Gold tip catheterExperimentalGold tip catheter
Receives: Device: Gold tip catheter
Platinum-iridium tip catheterActive comparatorPlatinum-iridium tip catheter
Receives: Device: Platinum-iridium tip catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: ablation procedure

Secondary outcomes (3)

  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.

    Measured: ablation procedure

  2. Number of Patients With Long-term Treatment Success

    No recurrence of atrial flutter after ablation

    Measured: 6 months after ablation

  3. Number of Patients With Charred Catheter Tips

    Char or coagulum formation on the catheter tip

    Measured: ablation procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2006 (estimated)
  2. Study startJun 2004
  3. Primary completionMar 2008
  4. Study completionMar 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
463 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00326001
Sponsor's protocol ID
EP016
Status last verified
Aug 2009
First submitted
12 May 2006
Last updated
18 Feb 2010

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Gold tip catheter and Platinum-iridium tip catheter in people with Atrial Flutter, run by Biotronik SE & Co. KG at 28 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Germany, Hungary, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of Energy Application (time frame: ablation procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00326001, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2010; AzTrials last refreshed its copy on 8 Nov 2026.

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