Isthmus Ablation With Gold Electrode for Treatment of Atrial Flutter (AURUM 8) - Full Text View

Sponsor:	Biotronik SE & Co. KG
Information provided by:	Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:	NCT00326001

Purpose

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	Intervention	Phase
Atrial Flutter	Device: Gold tip catheter Device: Platinum-iridium tip catheter	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

U.S. FDA Resources

Further study details as provided by Biotronik SE & Co. KG:

Primary Outcome Measures:

Duration of Energy Application [ Time Frame: ablation procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Ablation Success With the First Catheter [ Time Frame: ablation procedure ] [ Designated as safety issue: Yes ]
Number of Patients With Long-term Treatment Success [ Time Frame: 6 months after ablation ] [ Designated as safety issue: No ]
Number of Patients With Charred Catheter Tips [ Time Frame: ablation procedure ] [ Designated as safety issue: Yes ]

Enrollment:	463
Study Start Date:	June 2004
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326001

Locations

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

Sponsors and Collaborators

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

More Information

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.

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. No abstract available.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2010 Sep 28.

ClinicalTrials.gov Identifier:	NCT00326001 History of Changes
Other Study ID Numbers:	EP016
Study First Received:	May 12, 2006
Results First Received:	May 13, 2009
Last Updated:	February 3, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Biotronik SE & Co. KG:

Transvenous Catheter Ablation
Radiofrequency Catheter Ablation
Atrial flutter
Catheter Ablation

Additional relevant MeSH terms:

Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012