From the Emergency Department Directly to Ablation of Atrial Fibrillation Study (NCT05294445) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
From the Emergency Department Directly to Ablation of Atrial Fibrillation Study
Germany350 participantsStarted 2021-12-15
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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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 adequa…