From the Emergency Department Directly to Ablation of Atrial Fibrillation Study (EMERGE-Cryo)

May 20, 2026 updated by: Asklepios proresearch

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 the patients who are hospitalized for AF are admitted through the emergency department. The steady increase of AF-related visits at the emergency departments therefore lead to a high number of hospitalizations. The direct costs of AF already amount to approximately 1% of total healthcare spending, driven by AF-related complications (e.g. stroke) and treatment costs (e.g. hospitalizations). These costs will increase dramatically unless AF is prevented and treated in a timely and effective manner.

Catheter ablation therapy has been proven to be safe and effective for the treatment of paroxysmal and persistent AF and is now standard in AF therapy. Several trials have shown that catheter ablation of AF is superior to antiarrhythmic drug therapy. As evidenced by the FIRE & ICE trial, cryoballoon ablation is non-inferior to the former goldstandard of radiofrequency current (RFC) energy. Importantly, it has been reported that cryoballoon ablation was associated with a reduction in resource use and costs as compared to RFC ablation of AF. These cost savings persisted over multiple healthcare systems.

However, data on the optimal timing of AF ablation is scarce. While there is evidence that catheter ablation is highly efficient in delaying progression from paroxysmal to persistent AF, there are only few trials evaluating a strategy of early treatment of AF, regarding the patients' medical history (CRYO-FIRST, EARLY-AF). Another trial investigated the utilization of a multidisciplinary AF treatment pathway in patients presenting to the emergency department, which resulted in reduction of admission rate and hospital stays but did not include catheter ablation of AF. However, there is no scientific evidence on a strategy of early treatment of atrial fibrillation comparing anti-arrhythmic drug therapy to catheter ablation in the large number of patients presenting to the emergency departments.

A well-known limitation of many trials investigating catheter ablation of AF, can be found during the trials follow up after ablation, as detection of AF recurrences can be challenging. The sensitivity of detecting asymptomatic episodes with intermittent 24-hours ECG-monitoring is low. The Heart Rhythm Society and the European Heart Rhythm Society encourage continuous arrhythmia monitoring due to the greater sensitivity in detecting symptomatic and asymptomatic AF recurrences but also when assessing the overall AF burden. Additionally, in an era of digital revolution, the AFNET incorporated the use of wearables, smartphones, hand held-devices and health-related apps to new approaches of AF management.

To evaluate the efficacy and safety of an early rhythm control treatment of AF by catheter ablation with the cryoballoon with particular respect to arrhythmia recurrence, rehospitalisation, heart failure and health care costs in patients presenting to the emergency department due to AF, a prospective randomized study is necessary.

Study Type

Interventional

Enrollment (Actual)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Nauheim, Germany, 61231
        • Kerckhoff-Klinik GmbH
      • Berlin, Germany, 13353
        • Deutsches Herzzentrum der Charité
      • Cologne, Germany, 50937
        • Herzzentrum Uniklinik Köln
      • Düsseldorf, Germany, 40217
        • Evangelisches Krankenhaus Düsseldorf
      • Frankfurt, Germany, 60431
        • Cardioangiologisches Zentrum Bethanien (CCB) am Markuskrankenhaus
      • Giessen, Germany, 35392
        • Universitätsklinikum Gießen
      • Hamburg, Germany, 20099
        • Asklepios Klinik St. Georg
      • Hamburg, Germany, 22763
        • AK Altona
      • Hamburg, Germany, 20246
        • Universitäres Herz- und Gefäßzentrum
      • Hamburg-Nord, Germany, 22417
        • AK Nord
      • Harburg, Germany, 21075
        • Asklepios Klinik Harburg
      • Münster, Germany, 48149
        • Universitatsklinikum Munster
      • Wiesbaden, Germany, 65189
        • St. Josefs-Hospital Wiesbaden GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group1: Cryo-AF-Ablation
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)
Cryo-AF-ablation of pulmonary vein (pulmonary vein isolation = PVI)
No Intervention: Group 2: Usual care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from any atrial tachyarrhythmia
Time Frame: 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
within 3 to 12 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AF burden (1)
Time Frame: within 3 to 12 months follow up
AF burden between 3 to 12 months after randomization. AF burden is defined as overall percentage of AF during the observed time
within 3 to 12 months follow up
AF burden (2)
Time Frame: within 0 to 12 months follow up
AF burden between 0 to 3, 3 to 6 and 6 to 12 months after randomization
within 0 to 12 months follow up
Freedom from atrial fibrillation
Time Frame: within 3 to 12 months follow up
Freedom from atrial fibrillation (AF) (>30 s)
within 3 to 12 months follow up
Freedom from atrial tachycardia and atrial flutter
Time Frame: within 3 to 12 months follow up
Freedom from atrial tachycardia and atrial flutter (AFl)
within 3 to 12 months follow up
symptomatic versus asymptomatic atrial tachyarrhythmia
Time Frame: within 3 to 12 months follow up
Analysis of amount of symptomatic versus asymptomatic atrial tachyarrhythmia recurrences
within 3 to 12 months follow up
Re-hospitalization rate
Time Frame: up to 12 months follow up
Re-hospitalization rate due to cardiovascular disease (AF, worsening of heart failure, cardiovascular disease)
up to 12 months follow up
Progression of heart failure
Time Frame: up to 12 months follow up
Progression of heart failure defined as trend in LV-EF and trend in BNP
up to 12 months follow up
Quality of life (AFEQT and EQ-5D-5L)
Time Frame: within 0 to 12 months follow up
Improvement of quality of life at 12 months compared to baseline (AFEQT and EQ-5D-5L Questionnaire)
within 0 to 12 months follow up
Safety / Complications
Time Frame: within 0 to 12 months follow up
Safety / Complications
within 0 to 12 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asklepios proresearch

Collaborators

Atrial Fibrillation Network
Medtronic Bakken Research

Investigators

  • Principal Investigator: Stephan Willems, MD, PhD, Asklepios Hospital St. Georg, Hamburg, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2021

Primary Completion (Estimated)

December 14, 2026

Study Completion (Estimated)

December 14, 2028

Study Registration Dates

First Submitted

March 4, 2022

First Submitted That Met QC Criteria

March 23, 2022

First Posted (Actual)

March 24, 2022

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #3794 - EMERGE-Cryo Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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