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

Atrial Flutter Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00326001
• Other study ID #: EP016
• Status: Completed
• Phase: Phase 4
• First received: May 12, 2006
• Last updated: February 3, 2010
• Start date: June 2004
• Est. completion date: March 2008

Study information

• Verified date: August 2009
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 463
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Flutter

Intervention

Device:
• Gold tip catheter
Radiofrquency ablation using gold tip catheter
• Platinum-iridium tip catheter
Radiofrequency ablation using platinum-iridium tip catheter

Locations

Country	Name	City	State
Czech Republic	Institute of Clinical and Experimental Medicine	Praha
Germany	Universitätsklinik der RWTH Aachen	Aachen
Germany	Kerckhoff Klinik	Bad Nauheim
Germany	Charité Campus Mitte, Medizinische Fakultät der Humboldt Universität zu Berlin	Berlin
Germany	Universitätsklinikum Charité, Campus Benjamin Franklin	Berlin
Germany	Universitätsklinikum Charité, Campus Buch Franz-Volhard-Klinik	Berlin
Germany	Universitätsklinikum Charité, Campus Virchow-Klinikum	Berlin
Germany	Vivantes Klinikum Am Urban	Berlin
Germany	Berufsgenossenschaftliche Kliniken, Bergmannsheil Universitätsklinik	Bochum
Germany	Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelms-Universität Bonn	Bonn
Germany	Elektrophysiologische Praxis am Zentralkrankenhaus Links Der Weser	Bremen
Germany	Evangelisches Krankenhaus Düsseldorf	Duesseldorf
Germany	Herzzentrum Duisburg	Duisburg
Germany	Georg-August-Universität, Universitätsklinikum Göttingen	Goettingen
Germany	Allgemeines Krankenhaus Altona	Hamburg
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitätskliniken des Saarlandes	Homburg/Saar
Germany	St. Vincentius Krankenhaus/St. Marien Krankenhaus - Abteilung für Innere Medizin III	Karlsruhe
Germany	Herzzentrum Leipzig GmbH	Leipzig
Germany	Universitätsklinikum Mainz	Mainz
Germany	Städtisches Krankenhaus München-Bogenhausen	München
Germany	Universitätsklinikum Ulm	Ulm
Germany	Klinikum der Stadt Villingen-Schwenningen GmbH	Villingen-Schwenningen
Germany	Medizinische Universitätsklinik Würzburg	Würzburg
Hungary	Semmelweis Medical University - Department of Cardiology	Budapest
Hungary	The Debrecen University of Medicine, Center of Medicine and Health Care Sciences, Clinical Department of Cardiology	Debrecen
Hungary	The University of Pecs	Pecs

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

Czech Republic,  Germany,  Hungary, 

References & Publications (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. — View 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, Lüderitz 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Energy Application		ablation procedure	No
Secondary	Ablation Success With the First Catheter		ablation procedure	Yes
Secondary	Number of Patients With Long-term Treatment Success		6 months after ablation	No
Secondary	Number of Patients With Charred Catheter Tips		ablation procedure	Yes