Clinical trial NCT00326001: Isthmus Ablation With Gold Electrode for Treatment of Atrial Flutter (AURUM 8)
Official title: AURUM 8 - Ablation of the Cavotricuspid Isthmus in Patients With Atrial Flutter Using an 8 mm Gold Alloy Tip Electrode
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Flutter
Keywords: Transvenous Catheter Ablation
Radiofrequency Catheter Ablation
Atrial flutter
Catheter Ablation
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2006-05-16
Enrollment: 463
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Duration of Energy Application
timeFrame: ablation procedure
Secondary outcomes:
measure: Ablation Success With the First Catheter
timeFrame: ablation procedure
measure: Number of Patients With Long-term Treatment Success
timeFrame: 6 months after ablation
measure: Number of Patients With Charred Catheter Tips
timeFrame: ablation procedure
Other outcomes:
Locations:
city: Praha
country: Czech Republic
facility: Institute of Clinical and Experimental Medicine
city: Aachen
country: Germany
facility: Universitätsklinik der RWTH Aachen
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik
city: Berlin
country: Germany
facility: Charité Campus Mitte, Medizinische Fakultät der Humboldt Universität zu Berlin
city: Berlin
country: Germany
facility: Vivantes Klinikum Am Urban
city: Berlin
country: Germany
facility: Universitätsklinikum Charité, Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Universitätsklinikum Charité, Campus Buch Franz-Volhard-Klinik
city: Berlin
country: Germany
facility: Universitätsklinikum Charité, Campus Virchow-Klinikum
city: Bochum
country: Germany
facility: Berufsgenossenschaftliche Kliniken, Bergmannsheil Universitätsklinik
city: Bonn
country: Germany
facility: Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelms-Universität Bonn
city: Bremen
country: Germany
facility: Elektrophysiologische Praxis am Zentralkrankenhaus Links Der Weser
city: Duesseldorf
country: Germany
facility: Evangelisches Krankenhaus Düsseldorf
city: Duisburg
country: Germany
facility: Herzzentrum Duisburg
city: Goettingen
country: Germany
facility: Georg-August-Universität, Universitätsklinikum Göttingen
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Allgemeines Krankenhaus Altona
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Homburg/Saar
country: Germany
facility: Universitätskliniken des Saarlandes
city: Karlsruhe
country: Germany
facility: St. Vincentius Krankenhaus/St. Marien Krankenhaus - Abteilung für Innere Medizin III
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: Mainz
country: Germany
facility: Universitätsklinikum Mainz
city: München
country: Germany
facility: Städtisches Krankenhaus München-Bogenhausen
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Villingen-Schwenningen
country: Germany
facility: Klinikum der Stadt Villingen-Schwenningen GmbH
city: Würzburg
country: Germany
facility: Medizinische Universitätsklinik Würzburg
city: Budapest
country: Hungary
facility: Semmelweis Medical University - Department of Cardiology
city: Debrecen
country: Hungary
facility: The Debrecen University of Medicine, Center of Medicine and Health Care Sciences, Clinical Department of Cardiology
city: Pecs
country: Hungary
facility: The University of Pecs
Study officials:
affiliation: Universitätsklinikum Bonn, Medizinische Klinik and Poliklinik II, Sigmund-Freud-Strasse 25, D-53105 Bonn, Germany
name: Thorsten Lewalter, Assoc. Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.