Phase 4 N=463 Randomized Treatment

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

Atrial Flutter

Bottom Line

View on ClinicalTrials.gov: NCT00326001 ↗

Enrolled (actual)

463

Serious AEs

7.1%

Results posted

Feb 2010

Primary outcome: Primary: Duration of Energy Application — 10.2; 10.9 minute — p=0.25

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Gold tip catheter (Device); Platinum-iridium tip catheter (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Biotronik SE & Co. KG
Primary completion: Mar 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Duration of Energy Application	10.2; 10.9	0.25
SECONDARY Ablation Success With the First Catheter	216; 195	0.042 sig
SECONDARY Number of Patients With Long-term Treatment Success	225; 213	0.53
SECONDARY Number of Patients With Charred Catheter Tips	11; 83	<0.001 sig

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00326001). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.