Status:
COMPLETED
Isthmus Ablation With Gold Electrode for Treatment of Atrial Flutter (AURUM 8)
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
Atrial Flutter
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 atri...
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 isthmu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
463 Patients enrolled
Trial Details
Trial ID
NCT00326001
Start Date
June 1 2004
End Date
March 1 2008
Last Update
February 18 2010
Active Locations (28)
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1
Institute of Clinical and Experimental Medicine
Prague, Czechia, 14021
2
Universitätsklinik der RWTH Aachen
Aachen, Germany, 52074
3
Kerckhoff Klinik
Bad Nauheim, Germany, 61231
4
Charité Campus Mitte, Medizinische Fakultät der Humboldt Universität zu Berlin
Berlin, Germany, 10117