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Clinical Trials in Germany / NCT05294445
Active, not recruiting Not applicable

From the Emergency Department Directly to Ablation of Atrial Fibrillation Study

NCT05294445 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2021-12-15
Last updated
2026-05-22

Condition(s) studied

Atrial Fibrillation (AF)

Investigational drug(s) / intervention(s)

Ablation of atrial fibrillation (AF)

Ablation of atrial fibrillation (AF): Cryo-AF-ablation of pulmonary vein (pulmonary vein isolation = PVI)

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (13)

FacilityCityRegionStatus
Kerckhoff-Klinik GmbH Bad Nauheim Germany
Deutsches Herzzentrum der Charité Berlin Germany
Herzzentrum Uniklinik Köln Cologne Germany
Evangelisches Krankenhaus Düsseldorf Düsseldorf Germany
Cardioangiologisches Zentrum Bethanien (CCB) am Markuskrankenhaus Frankfurt Germany
Universitätsklinikum Giessen Giessen Germany
Asklepios Klinik St. Georg Hamburg Germany
Universitäres Herz- und Gefäßzentrum Hamburg Germany
AK Altona Hamburg Germany
AK Nord Hamburg-Nord Germany
Asklepios Klinik Harburg Harburg Germany
Universitätsklinikum Münster Münster Germany
St. Josefs-Hospital Wiesbaden GmbH Wiesbaden Germany

More Asklepios proresearch trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05294445 on ClinicalTrials.gov ↗ ← All trials in Germany