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

This study has been completed.
Sponsor:
Information provided by:
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT00326001
First received: May 12, 2006
Last updated: February 3, 2010
Last verified: August 2009
  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 4

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 August 01, 2014