Isthmus Ablation With Gold Electrode for Treatment of Atrial Flutter (AURUM 8)
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|ClinicalTrials.gov Identifier: NCT00326001|
Recruitment Status : Completed
First Posted : May 16, 2006
Results First Posted : February 4, 2010
Last Update Posted : February 18, 2010
|Condition or disease||Intervention/treatment||Phase|
|Atrial Flutter||Device: Gold tip catheter Device: Platinum-iridium tip catheter||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||463 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||AURUM 8 - Ablation of the Cavotricuspid Isthmus in Patients With Atrial Flutter Using an 8 mm Gold Alloy Tip Electrode|
|Study Start Date :||June 2004|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||March 2008|
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
- Duration of Energy Application [ Time Frame: 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.
- Ablation Success With the First Catheter [ Time Frame: 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 [ Time Frame: 6 months after ablation ]No recurrence of atrial flutter after ablation
- Number of Patients With Charred Catheter Tips [ Time Frame: ablation procedure ]Char or coagulum formation on the catheter tip
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00326001
|Principal Investigator:||Thorsten Lewalter, Assoc. Prof. Dr.||Universitätsklinikum Bonn, Medizinische Klinik and Poliklinik II, Sigmund-Freud-Strasse 25, D-53105 Bonn, Germany|