Isthmus Ablation With Gold Electrode for Treatment of Atrial Flutter (AURUM 8)
Atrial Flutter
About this trial
This is an interventional treatment trial for Atrial Flutter focused on measuring Transvenous Catheter Ablation, Radiofrequency Catheter Ablation, Atrial flutter, Catheter Ablation
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
Sites / Locations
- Institute of Clinical and Experimental Medicine
- Universitätsklinik der RWTH Aachen
- Kerckhoff Klinik
- Charité Campus Mitte, Medizinische Fakultät der Humboldt Universität zu Berlin
- Vivantes Klinikum Am Urban
- Universitätsklinikum Charité, Campus Benjamin Franklin
- Universitätsklinikum Charité, Campus Buch Franz-Volhard-Klinik
- Universitätsklinikum Charité, Campus Virchow-Klinikum
- Berufsgenossenschaftliche Kliniken, Bergmannsheil Universitätsklinik
- Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelms-Universität Bonn
- Elektrophysiologische Praxis am Zentralkrankenhaus Links Der Weser
- Evangelisches Krankenhaus Düsseldorf
- Herzzentrum Duisburg
- Georg-August-Universität, Universitätsklinikum Göttingen
- Universitätsklinikum Hamburg-Eppendorf
- Allgemeines Krankenhaus Altona
- Medizinische Hochschule Hannover
- Universitätskliniken des Saarlandes
- St. Vincentius Krankenhaus/St. Marien Krankenhaus - Abteilung für Innere Medizin III
- Herzzentrum Leipzig GmbH
- Universitätsklinikum Mainz
- Städtisches Krankenhaus München-Bogenhausen
- Universitätsklinikum Ulm
- Klinikum der Stadt Villingen-Schwenningen GmbH
- Medizinische Universitätsklinik Würzburg
- Semmelweis Medical University - Department of Cardiology
- The Debrecen University of Medicine, Center of Medicine and Health Care Sciences, Clinical Department of Cardiology
- The University of Pecs
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Gold tip catheter
Platinum-iridium tip catheter
Gold tip catheter
Platinum-iridium tip catheter