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