Direct Ablation for Atrial Fibrillation from the Emergency Department
From the Emergency Department Directly to Ablation of Atrial Fibrillation - Study - The "EMERGE-Cryo-Study"
This study tests if giving immediate catheter ablation to patients with recent atrial fibrillation in the emergency department can lead to better health outcomes and fewer hospital visits compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Asklepios proresearch Industry-sponsored |
| Locations | 13 sites (Bad Nauheim and 12 other locations) |
| Trial ID | NCT05294445 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with documented recent-onset paroxysmal or persistent atrial fibrillation who present to the emergency department.
Not a fit: Patients with a history of persistent AF lasting more than six months or those with significant heart valve issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce hospitalizations and improve the quality of life for patients with atrial fibrillation.
How similar studies have performed: Previous studies have shown that catheter ablation is effective for AF treatment, but this specific approach of immediate ablation from the emergency department is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bad Nauheim and 12 other locations
- Kerckhoff-Klinik GmbH — Bad Nauheim, Germany (Recruiting)
- Deutsches Herzzentrum der Charité — Berlin, Germany (Recruiting)
- Evangelisches Krankenhaus Düsseldorf — Düsseldorf, Germany (Active_not_recruiting)
- Cardioangiologisches Zentrum Bethanien (CCB) am Markuskrankenhaus — Frankfurt, Germany (Recruiting)
- Universitätsklinikum Giessen — Gießen, Germany (Recruiting)
- Asklepios Klinik Harburg — Hamburg-Harburg, Germany (Recruiting)
- AK Nord — Hamburg-Nord, Germany (Active_not_recruiting)
- Asklepios Klinik St. Georg — Hamburg, Germany (Recruiting)
- Universitäres Herz- und Gefäßzentrum — Hamburg, Germany (Recruiting)
- AK Altona — Hamburg, Germany (Recruiting)
- Herzzentrum Uniklinik Köln — Köln, Germany (Recruiting)
- Universitätsklinikum Münster — Münster, Germany (Recruiting)
- St. Josefs-Hospital Wiesbaden GmbH — Wiesbaden, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.