Status:
RECRUITING
From the Emergency Department Directly to Ablation of Atrial Fibrillation Study
Lead Sponsor:
Asklepios proresearch
Collaborating Sponsors:
Atrial Fibrillation Network
Medtronic Bakken Research
Conditions:
Atrial Fibrillation (AF)
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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 rec...
Detailed Description
As stated in the current guidelines, the prevalence of AF tripled over the last 30 years and further progress is expected. AF is associated with increased mortality and morbidity. Approximately 70% of...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 14 2028
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT05294445
Start Date
December 15 2021
End Date
December 14 2028
Last Update
April 10 2025
Active Locations (13)
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1
Asklepios Klinik St. Georg
Hamburg, Hamburg, Germany, 20099
2
Universitäres Herz- und Gefäßzentrum
Hamburg, Hamburg, Germany, 20246
3
Kerckhoff-Klinik GmbH
Bad Nauheim, Germany, 61231
4
Deutsches Herzzentrum der Charité
Berlin, Germany, 13353