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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Biotronik SE & Co. KG

Current Primary Outcome: Duration of Energy Application [ Time Frame: ablation procedure ]

Original Primary Outcome: Duration of Energy Application

Current Secondary Outcome:

  • Ablation Success With the First Catheter [ Time Frame: ablation procedure ]
  • Number of Patients With Long-term Treatment Success [ Time Frame: 6 months after ablation ]
  • Number of Patients With Charred Catheter Tips [ Time Frame: ablation procedure ]


Original Secondary Outcome:

  • Success rate
  • Acute and long-term treatment success
  • Comparison of ablation parameters


Information By: Biotronik SE & Co. KG

Dates:
Date Received: May 12, 2006
Date Started: June 2004
Date Completion:
Last Updated: February 3, 2010
Last Verified: August 2009