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Active Not Recruiting NCT05294445

From the Emergency Department Directly to Ablation of Atrial Fibrillation Study

Conditions: Atrial Fibrillation (AF)

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 350
Sponsor: Asklepios proresearch

Location: Kerckhoff-Klinik GmbH Bad Nauheim

Summary

The study is a prospective, two-arm, randomized, open-label, blinded endpoint, multi-center study to investigate the impact of first line ablation in patients presenting at the emergency room with recent-onset paroxysmal or persistent atrial fibrillation.

Eligibility Criteria

Inclusion Criteria: * Documented, paroxysmal or persistent AF (longest AF episode \< 6-month duration). Any ECG documentation of AF (12 lead ECG, Holter ECG or mobile ECG monitoring) needs to be presented. * Recent-onset AF (≤ 1 year prior to enrolment) * Presenting at the emergency department or outpatient clinic within the last 2 weeks because of AF, including patients with spontaneous conversion in sinus rhythm (with prior AF documentation) * Age ≥ 18 years * Subject is able and willing to give informed consent Exclusion Criteria * Pers. AF \> 6 Mon (one episode) * LA-Diameter \> 60mm * Severe mitral stenosis or regurgitation, prior mitral valve reconstruction or replacement * Any previous left atrial ablation * Ongoing continuous AAD therapy with Amiodarone at baseline * History of failed continuous AAD therapy with \> 1 agent. Exceptions are Beta blocker, Verapamil or "pill in the pocket"-therapy. * Any condition or disease, which is contraindication for AF ablation, up to the assessment of the investigator * Any condition or disease, which is a contraindication for antiarrhythmic drug treatment, up to the assessment of the investigator * Known intra-cardiac thrombus formation under continuous oral anticoagulation (defined as intake \>4 weeks) * Any contraindication for oral anticoagulation * Any untreated or uncontrolled hyperthyroidism or other reversible causes for AF like alcoholism * Pregnant or breastfeeding woman or woman of childbearing potential not on adequate birth control * Active systemic infection * Co-Existence of non PV-dependent atrial Tachycardia * Indication for implantation of ICD or pacemaker

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05294445). StuddyBuddy aggregates publicly available trial information.