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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gold tip catheter | Experimental | Gold tip catheter |
|
| Platinum-iridium tip catheter | Active Comparator | Platinum-iridium tip catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gold tip catheter | Device | Radiofrquency ablation using gold tip catheter |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Energy Application | 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. | ablation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Ablation Success With the First Catheter | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Late Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thorsten Lewalter, Assoc. Prof. Dr. | Universitätsklinikum Bonn, Medizinische Klinik and Poliklinik II, Sigmund-Freud-Strasse 25, D-53105 Bonn, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Clinical and Experimental Medicine | Prague | 14021 | Czechia | |||
| Universitätsklinik der RWTH Aachen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16050836 | Background | 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. | |
| 16403084 |
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No exclusion before assignment
A total of 463 patients were enrolled in the AURUM 8 study from June 2004 to March 2007 in 19 clinical centers in Germany and the Czech Republic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gold Tip Catheter | Patients allocated to be ablated by 8-mm gold tip catheter |
| FG001 | Pt-Ir Tip Catheter | Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Platinum-iridium tip catheter |
| Device |
Radiofrequency ablation using platinum-iridium tip catheter |
|
| ablation procedure |
| Number of Patients With Long-term Treatment Success | No recurrence of atrial flutter after ablation | 6 months after ablation |
| Number of Patients With Charred Catheter Tips | Char or coagulum formation on the catheter tip | ablation procedure |
| Aachen |
| 52074 |
| Germany |
| Kerckhoff Klinik | Bad Nauheim | 61231 | Germany |
| Charité Campus Mitte, Medizinische Fakultät der Humboldt Universität zu Berlin | Berlin | 10117 | Germany |
| Vivantes Klinikum Am Urban | Berlin | 10967 | Germany |
| Universitätsklinikum Charité, Campus Benjamin Franklin | Berlin | 12200 | Germany |
| Universitätsklinikum Charité, Campus Buch Franz-Volhard-Klinik | Berlin | 13125 | Germany |
| Universitätsklinikum Charité, Campus Virchow-Klinikum | Berlin | 13353 | Germany |
| Berufsgenossenschaftliche Kliniken, Bergmannsheil Universitätsklinik | Bochum | 44789 | Germany |
| Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelms-Universität Bonn | Bonn | 53105 | Germany |
| Elektrophysiologische Praxis am Zentralkrankenhaus Links Der Weser | Bremen | 28277 | Germany |
| Herzzentrum Duisburg | Duisburg | 47137 | Germany |
| Evangelisches Krankenhaus Düsseldorf | Düsseldorf | 40217 | Germany |
| Georg-August-Universität, Universitätsklinikum Göttingen | Göttingen | 37099 | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Allgemeines Krankenhaus Altona | Hamburg | 22763 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Universitätskliniken des Saarlandes | Homburg/Saar | 66421 | Germany |
| St. Vincentius Krankenhaus/St. Marien Krankenhaus - Abteilung für Innere Medizin III | Karlsruhe | 76137 | Germany |
| Herzzentrum Leipzig GmbH | Leipzig | 04289 | Germany |
| Universitätsklinikum Mainz | Mainz | 55131 | Germany |
| Städtisches Krankenhaus München-Bogenhausen | München | 81925 | Germany |
| Universitätsklinikum Ulm | Ulm | 89070 | Germany |
| Klinikum der Stadt Villingen-Schwenningen GmbH | Villingen-Schwenningen | 78050 | Germany |
| Medizinische Universitätsklinik Würzburg | Würzburg | 97080 | Germany |
| Semmelweis Medical University - Department of Cardiology | Budapest | 1122 | Hungary |
| The Debrecen University of Medicine, Center of Medicine and Health Care Sciences, Clinical Department of Cardiology | Debrecen | 4032 | Hungary |
| The University of Pecs | Pécs | 7624 | Hungary |
| Background |
| 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. |
| 23379836 | Derived | 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. |
| 20876601 | Derived | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Gold Tip Catheter | Patients allocated to be ablated by 8-mm gold tip catheter |
| BG001 | Pt-Ir Tip Catheter | Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of Energy Application | 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. | Per protocol | Posted | May 2009 | Mean | Standard Deviation | minute | ablation procedure |
|
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| Secondary | Ablation Success With the First Catheter | 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. | per protocol | Posted | Number | Patients | ablation procedure |
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| Secondary | Number of Patients With Long-term Treatment Success | No recurrence of atrial flutter after ablation | per protocol | Posted | Number | Patients | 6 months after ablation |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Charred Catheter Tips | Char or coagulum formation on the catheter tip | per protocol | Posted | Number | Patients | ablation procedure |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gold Tip Catheter | Patients allocated to be ablated by 8-mm gold tip catheter | 20 | 229 | 0 | 229 | ||
| EG001 | Pt-Ir Tip Catheter | Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter | 12 | 219 | 0 | 219 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Non-systematic Assessment | Death for any cause |
| |
| Hospitalization | General disorders | Non-systematic Assessment | Hospitalization for any cause |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dejan Danilovic | Biotronik GmbH&Co. KG, Berlin, Germany | +49 9131 8924 7832 | dejan.danilovic@biotronik.com |
| ID | Term |
|---|---|
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
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| Male |
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| Germany |
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