Direct Ablation for Atrial Fibrillation from the Emergency Department

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of immediate catheter ablation for patients with recent-onset paroxysmal or persistent atrial fibrillation (AF) who present to the emergency department. It is a prospective, two-arm, randomized, open-label study that aims to determine if early intervention can improve outcomes and reduce hospitalizations associated with AF. The study will compare the outcomes of patients receiving ablation therapy directly from the emergency department to those receiving standard care. The goal is to address the rising prevalence and healthcare costs associated with AF by providing timely treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• Kerckhoff-Klinik GmbH
  Bad Nauheim, Germany Recruiting
• Deutsches Herzzentrum der Charité
  Berlin, Germany Recruiting
• Cardioangiologisches Zentrum Bethanien (CCB) am Markuskrankenhaus
  Frankfurt, Germany Recruiting
• Universitätsklinikum Giessen
  Gießen, Germany Recruiting
• Asklepios Klinik Harburg
  Hamburg-Harburg, Germany Recruiting
• Asklepios Klinik St. Georg
  Hamburg, Germany Recruiting

Study contacts

• Principal investigator: Stephan Willems, MD, PhD — Asklepios Hospital St. Georg, Hamburg, Germany
• Study coordinator: Nele Gessler, MD, PhD
• Email: n.gessler@asklepios.com
• Phone: +49-40-181885-3069

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.