From the Emergency Department Directly to Ablation of Atrial Fibrillation Study

NCT05294445 | Active Not Recruiting

• 1 other identifier: #3794 - EMERGE-Cryo Study
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 13

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 recent-onset paroxysmal or persistent atrial fibrillation.

Conditions

Atrial Fibrillation (AF)

Keywords

Ablation

Outcome Measures

Primary Outcomes (1)

• Freedom from any atrial tachyarrhythmia

  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

  within 3 to 12 months follow-up

Secondary Outcomes (9)

• AF burden (1)

  within 3 to 12 months follow up

• AF burden (2)

  within 0 to 12 months follow up

• Freedom from atrial fibrillation

  within 3 to 12 months follow up

• Freedom from atrial tachycardia and atrial flutter

  within 3 to 12 months follow up

• symptomatic versus asymptomatic atrial tachyarrhythmia

  within 3 to 12 months follow up

Study Arms (2)

Group1: Cryo-AF-Ablation

ACTIVE COMPARATOR

Patients randomized in the Cryo-AF-Ablation group should receive the cryo AF ablation within 21 days from baseline.

Procedure: Ablation of atrial fibrillation (AF)

Group 2: Usual care

NO INTERVENTION

Patients randomized in the usual care group should start or maintain on AAD therapy within 21 days from baseline, based on decision of the investigator according to current ESC Guidelines.

Interventions

Ablation of atrial fibrillation (AF) PROCEDURE

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

Group1: Cryo-AF-Ablation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asklepios proresearch: lead
• Atrial Fibrillation Network: collaborator
• Medtronic Bakken Research: collaborator

Study Sites (13)

Kerckhoff-Klinik GmbH

Bad Nauheim, 61231, Germany

Location

Deutsches Herzzentrum der Charité

Berlin, 13353, Germany

Location

Herzzentrum Uniklinik Köln

Cologne, 50937, Germany

Location

Evangelisches Krankenhaus Düsseldorf

Düsseldorf, 40217, Germany

Location

Cardioangiologisches Zentrum Bethanien (CCB) am Markuskrankenhaus

Frankfurt, 60431, Germany

Location

Universitätsklinikum Giessen

Giessen, 35392, Germany

Location

Asklepios Klinik St. Georg

Hamburg, 20099, Germany

Location

Universitäres Herz- und Gefäßzentrum

Hamburg, 20246, Germany

Location

AK Altona

Hamburg, 22763, Germany

Location

AK Nord

Hamburg-Nord, 22417, Germany

Location

Asklepios Klinik Harburg

Harburg, 21075, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

St. Josefs-Hospital Wiesbaden GmbH

Wiesbaden, 65189, Germany

Location

Related Publications (22)

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MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephan Willems, MD, PhD

  Asklepios Hospital St. Georg, Hamburg, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Additionally to ILR interrogation on each site, the ILR data will be reviewed by blinded core lab investigators. All observed primary endpoints and outcome parameters will be presented to ERC.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: prospective, two-arm, randomized, open-label, blinded endpoint, multi-center study

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 24, 2022
• Study Start: December 15, 2021
• Primary Completion (Estimated): December 14, 2026
• Study Completion (Estimated): December 14, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

DE (13)