NCT00326001

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 463 (actual)
• Sponsor: Biotronik SE & Co. KG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Flutter

Interventions

Type	Name	Description
DEVICE	Gold tip catheter	Radiofrquency ablation using gold tip catheter
DEVICE	Platinum-iridium tip catheter	Radiofrequency ablation using platinum-iridium tip catheter

Timeline

• Start date: 2004-06-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2006-05-16
• Last updated: 2010-02-18
• Results posted: 2010-02-04

Locations

28 sites across 3 countries: Czechia, Germany, Hungary