Isthmus Ablation With Gold Electrode for Treatment of Atrial Flutter (AURUM 8)
- Conditions
- Atrial Flutter
- Interventions
- Device: Gold tip catheterDevice: Platinum-iridium tip catheter
- Registration Number
- NCT00326001
- Lead Sponsor
- Biotronik SE & Co. KG
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 463
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gold tip catheter Gold tip catheter Gold tip catheter Platinum-iridium tip catheter Platinum-iridium tip catheter Platinum-iridium tip catheter
- Primary Outcome Measures
Name Time Method Duration of Energy Application ablation procedure 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.
- Secondary Outcome Measures
Name Time Method Ablation Success With the First Catheter ablation procedure 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.Number of Patients With Long-term Treatment Success 6 months after ablation No recurrence of atrial flutter after ablation
Number of Patients With Charred Catheter Tips ablation procedure Char or coagulum formation on the catheter tip
Trial Locations
- Locations (28)
Charité Campus Mitte, Medizinische Fakultät der Humboldt Universität zu Berlin
🇩🇪Berlin, Germany
The University of Pecs
🇭🇺Pecs, Hungary
Evangelisches Krankenhaus Düsseldorf
🇩🇪Duesseldorf, Germany
Universitätsklinikum Charité, Campus Benjamin Franklin
🇩🇪Berlin, Germany
Universitätsklinikum Charité, Campus Buch Franz-Volhard-Klinik
🇩🇪Berlin, Germany
Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelms-Universität Bonn
🇩🇪Bonn, Germany
Universitätskliniken des Saarlandes
🇩🇪Homburg/Saar, Germany
Kerckhoff Klinik
🇩🇪Bad Nauheim, Germany
Vivantes Klinikum Am Urban
🇩🇪Berlin, Germany
Berufsgenossenschaftliche Kliniken, Bergmannsheil Universitätsklinik
🇩🇪Bochum, Germany
Städtisches Krankenhaus München-Bogenhausen
🇩🇪München, Germany
Institute of Clinical and Experimental Medicine
🇨🇿Praha, Czech Republic
Georg-August-Universität, Universitätsklinikum Göttingen
🇩🇪Goettingen, Germany
Elektrophysiologische Praxis am Zentralkrankenhaus Links Der Weser
🇩🇪Bremen, Germany
Universitätsklinikum Charité, Campus Virchow-Klinikum
🇩🇪Berlin, Germany
Herzzentrum Duisburg
🇩🇪Duisburg, Germany
Allgemeines Krankenhaus Altona
🇩🇪Hamburg, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Universitätsklinik der RWTH Aachen
🇩🇪Aachen, Germany
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
St. Vincentius Krankenhaus/St. Marien Krankenhaus - Abteilung für Innere Medizin III
🇩🇪Karlsruhe, Germany
Herzzentrum Leipzig GmbH
🇩🇪Leipzig, Germany
Universitätsklinikum Mainz
🇩🇪Mainz, Germany
Semmelweis Medical University - Department of Cardiology
🇭🇺Budapest, Hungary
Klinikum der Stadt Villingen-Schwenningen GmbH
🇩🇪Villingen-Schwenningen, Germany
Medizinische Universitätsklinik Würzburg
🇩🇪Würzburg, Germany
The Debrecen University of Medicine, Center of Medicine and Health Care Sciences, Clinical Department of Cardiology
🇭🇺Debrecen, Hungary
Universitätsklinikum Ulm
🇩🇪Ulm, Germany