RecruitingNot ApplicableNCT05294445

From the Emergency Department Directly to Ablation of Atrial Fibrillation Study

From the Emergency Department Directly to Ablation of Atrial Fibrillation - Study - The "EMERGE-Cryo-Study"


Sponsor

Asklepios proresearch

Enrollment

350 participants

Start Date

Dec 15, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria5

  • 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 Criteria15

  • 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

Interventions

PROCEDUREAblation of atrial fibrillation (AF)

Cryo-AF-ablation of pulmonary vein (pulmonary vein isolation = PVI)


Locations(13)

Asklepios Klinik St. Georg

Hamburg, Hamburg, Germany

Universitäres Herz- und Gefäßzentrum

Hamburg, Hamburg, Germany

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

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

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NCT05294445


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