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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Flutter
• Intervention / Treatment: Device: Gold tip catheter; Device: Platinum-iridium tip catheter

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: Interventional
• Enrollment (Actual): 463
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gold tip catheter	Device: Gold tip catheter; Radiofrquency ablation using gold tip catheter
Active Comparator: Platinum-iridium tip catheter	Device: Platinum-iridium tip catheter; Radiofrequency ablation using platinum-iridium tip catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	ablation procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	ablation procedure
Number of Patients With Long-term Treatment Success	No recurrence of atrial flutter after ablation	6 months after ablation
Number of Patients With Charred Catheter Tips	Char or coagulum formation on the catheter tip	ablation procedure

Collaborators and Investigators

• Sponsor: Biotronik SE & Co. KG
• Investigators: Principal Investigator: Thorsten Lewalter, Assoc. Prof. Dr., Universitätsklinikum Bonn, Medizinische Klinik and Poliklinik II, Sigmund-Freud-Strasse 25, D-53105 Bonn, Germany

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: May 12, 2006
• First Submitted That Met QC Criteria: May 12, 2006
• First Posted (Estimate): May 16, 2006

Study Record Updates

• Last Update Posted (Estimate): February 18, 2010
• Last Update Submitted That Met QC Criteria: February 3, 2010
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: Catheter Ablation; Atrial flutter; Radiofrequency Catheter Ablation; Transvenous Catheter Ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Flutter
• Other Study ID Numbers: EP016