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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Atrial Flutter

Intervention / Treatment
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* Device: Gold tip catheter
* Device: Platinum-iridium tip catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least one electrocardiogram (ECG)-documented (can be older than 3 months), symptomatic, typical atrial flutter episode with either negative, sawtooth-shaped P-waves in leads II, III, and augmented voltage foot (aVF), or positive P-waves in leads II, III, and aVF At least one persistent, typical atrial flutter episode of over 2 hours that has been documented in the history in the patient file and/or ECG Signed informed consent form Exclusion Criteria: Patient has recently undergone isthmus ablation Acute coronary syndrome or myocardial infarction within the last 3 months Acute reversible causes for atrial flutter (e.g. acute myocarditis) Severe cardiac valvular defects Tricuspid valve replacement Atrial septum defect Cardiovascular surgery scheduled within the next 6 months Unstable medication in the last 7 days before study inclusion New York Heart Association (NYHA) class IV Women who are breastfeeding Pregnancy Abuse of drugs or alcohol Patient is unable to participate in follow-up examinations The patient has only partial legal competence Participation in another clinical study The ablation procedure presents an above average risk to the patient as compared to the normal patient group (must be noted by the physician on the appropriate form). Right atrial thrombus Late Exclusion Criteria: Patient included by accident Premature termination of the ablation procedure Atrial flutter not dependent on the posterior isthmus No conduction at the posterior isthmus before ablation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gold tip catheter<br>Gold tip catheter | Device: Gold tip catheter<br>* Radiofrquency ablation using gold tip catheter<br>|
| Active Comparator: Platinum-iridium tip catheter<br>Platinum-iridium tip catheter | Device: Platinum-iridium tip catheter<br>* Radiofrequency ablation using platinum-iridium tip catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transvenous Catheter Ablation, Radiofrequency Catheter Ablation, Atrial flutter, Catheter Ablation