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)
Freedom from any atrial tachyarrhythmia — within 3 to 12 months follow-up Freedom from any atrial tachyarrhythmia, including atrial fibrillation (AF), atrial flutter and atrial tachycardias (\>30 s) through 3 to 12 months follow-up on ILR monitoring or any 12 lead ECG on visits, ECG Holter monitoring, or on symptom driven event monitoring
Trial sites (13)
Facility
City
Region
Status
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
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.
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