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Atrial Fibrillation (AF)EMERGE-CryoNCT05294445

From the Emergency Department Directly to Ablation of Atrial Fibrillation Study

A study testing Ablation of atrial fibrillation (AF) in people with Atrial Fibrillation (AF), run by Asklepios proresearch at 13 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation (AF)
What is being tested?
Ablation of atrial fibrillation (AF)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
13 sitesGermany
Study dates
15 Dec 2021to 14 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 15Show fewer
  • 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Germany13 sites

  • Kerckhoff-Klinik GmbH

    Bad Nauheim, 61231

  • Deutsches Herzzentrum der Charité

    Berlin, 13353

  • Herzzentrum Uniklinik Köln

    Cologne, 50937

  • Evangelisches Krankenhaus Düsseldorf

    Düsseldorf, 40217

  • Cardioangiologisches Zentrum Bethanien (CCB) am Markuskrankenhaus

    Frankfurt, 60431

  • Universitätsklinikum Giessen

    Giessen, 35392

  • Asklepios Klinik St. Georg

    Hamburg, 20099

  • Universitäres Herz- und Gefäßzentrum

    Hamburg, 20246

  • AK Altona

    Hamburg, 22763

  • AK Nord

    Hamburg-Nord, 22417

  • Asklepios Klinik Harburg

    Harburg, 21075

  • Universitätsklinikum Münster

    Münster, 48149

  • St. Josefs-Hospital Wiesbaden GmbH

    Wiesbaden, 65189

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Being tested
Ablation of atrial fibrillation (AF)
Keywords
Ablation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ablation of atrial fibrillation (AF)Procedure or surgery

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

Study groups in NCT05294445
Study groupRoleWhat they receive
Group1: Cryo-AF-AblationActive comparatorPatients randomized in the Cryo-AF-Ablation group should receive the cryo AF ablation within 21 days from baseline.
Receives: Procedure: Ablation of atrial fibrillation (AF)
Group 2: Usual careNo interventionPatients 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 being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: within 3 to 12 months follow-up

Secondary outcomes (9)

  1. AF burden (1)

    AF burden between 3 to 12 months after randomization. AF burden is defined as overall percentage of AF during the observed time

    Measured: within 3 to 12 months follow up

  2. AF burden (2)

    AF burden between 0 to 3, 3 to 6 and 6 to 12 months after randomization

    Measured: within 0 to 12 months follow up

  3. Freedom from atrial fibrillation

    Freedom from atrial fibrillation (AF) (>30 s)

    Measured: within 3 to 12 months follow up

  4. Freedom from atrial tachycardia and atrial flutter

    Freedom from atrial tachycardia and atrial flutter (AFl)

    Measured: within 3 to 12 months follow up

  5. symptomatic versus asymptomatic atrial tachyarrhythmia

    Analysis of amount of symptomatic versus asymptomatic atrial tachyarrhythmia recurrences

    Measured: within 3 to 12 months follow up

  6. Re-hospitalization rate

    Re-hospitalization rate due to cardiovascular disease (AF, worsening of heart failure, cardiovascular disease)

    Measured: up to 12 months follow up

  7. Progression of heart failure

    Progression of heart failure defined as trend in LV-EF and trend in BNP

    Measured: up to 12 months follow up

  8. Quality of life (AFEQT and EQ-5D-5L)

    Improvement of quality of life at 12 months compared to baseline (AFEQT and EQ-5D-5L Questionnaire)

    Measured: within 0 to 12 months follow up

  9. Safety / Complications

    Safety / Complications

    Measured: within 0 to 12 months follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2022
  2. Study start15 Dec 2021
  3. Primary completion16 Nov 2026 (estimated)
  4. Study completion14 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
prospective, two-arm, randomized, open-label, blinded endpoint, multi-center study
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
350 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05294445
Sponsor's protocol ID
#3794 - EMERGE-Cryo Study
Acronym
EMERGE-Cryo
Status last verified
May 2026
First submitted
4 Mar 2022
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Packer DL, Mark DB, Robb RA, Monahan KH, Bahnson TD, Poole JE, Noseworthy PA, Rosenberg YD, Jeffries N, Mitchell LB, Flaker GC, Pokushalov E, Romanov A, Bunch TJ, Noelker G, Ardashev A, Revishvili A, Wilber DJ, Cappato R, Kuck KH, Hindricks G, Davies DW, Kowey PR, Naccarelli GV, Reiffel JA, Piccini JP, Silverstein AP, Al-Khalidi HR, Lee KL; CABANA Investigators. Effect of Catheter Ablation vs Antiarrhythmic Drug Therapy on Mortality, Stroke, Bleeding, and Cardiac Arrest Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial. JAMA. 2019 Apr 2;321(13):1261-1274. doi: 10.1001/jama.2019.0693.

    PubMed 30874766

  • Asad ZUA, Yousif A, Khan MS, Al-Khatib SM, Stavrakis S. Catheter Ablation Versus Medical Therapy for Atrial Fibrillation: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Circ Arrhythm Electrophysiol. 2019 Sep;12(9):e007414. doi: 10.1161/CIRCEP.119.007414. Epub 2019 Aug 21.

    PubMed 31431051

  • Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P; ESC Scientific Document Group. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016 Oct 7;37(38):2893-2962. doi: 10.1093/eurheartj/ehw210. Epub 2016 Aug 27. No abstract available.

    PubMed 27567408

  • Gunawardene MA, Hoffmann BA, Schaeffer B, Chung DU, Moser J, Akbulak RO, Jularic M, Eickholt C, Nuehrich J, Meyer C, Willems S. Influence of energy source on early atrial fibrillation recurrences: a comparison of cryoballoon vs. radiofrequency current energy ablation with the endpoint of unexcitability in pulmonary vein isolation. Europace. 2018 Jan 1;20(1):43-49. doi: 10.1093/europace/euw307.

    PubMed 27742775

  • Gunawardene MA, Hartmann J, Jularic M, Eickholt C, Gessler N, Willems S. [Therapeutic management of nonvalvular atrial fibrillation]. Herz. 2020 Sep;45(6):603-616. doi: 10.1007/s00059-020-04960-w. German.

    PubMed 32632547

  • Gunawardene MA, Eickholt C, Akbulak RO, Jularic M, Klatt N, Hartmann J, Schluter M, Meyer C, Willems S, Schaeffer B. Ultra-high-density mapping of conduction gaps and atrial tachycardias: Distinctive patterns following pulmonary vein isolation with cryoballoon or contact-force-guided radiofrequency current. J Cardiovasc Electrophysiol. 2020 May;31(5):1051-1061. doi: 10.1111/jce.14413. Epub 2020 Mar 9.

    PubMed 32107811

  • Schmidt M, Dorwarth U, Andresen D, Brachmann J, Kuck KH, Kuniss M, Lewalter T, Spitzer S, Willems S, Senges J, Junger C, Hoffmann E. Cryoballoon versus RF ablation in paroxysmal atrial fibrillation: results from the German Ablation Registry. J Cardiovasc Electrophysiol. 2014 Jan;25(1):1-7. doi: 10.1111/jce.12267. Epub 2013 Oct 17.

    PubMed 24134539

  • Dinshaw L, Schaffer B, Akbulak O, Jularic M, Hartmann J, Klatt N, Dickow J, Gunawardene M, Munkler P, Hakmi S, Pecha S, Sultan A, Luker J, Pinnschmidt H, Hoffmann B, Gosau N, Eickholt C, Willems S, Steven D, Meyer C. Long-term efficacy and safety of radiofrequency catheter ablation of atrial fibrillation in patients with cardiac implantable electronic devices and transvenous leads. J Cardiovasc Electrophysiol. 2019 May;30(5):679-687. doi: 10.1111/jce.13890. Epub 2019 Mar 10.

    PubMed 30821012

  • Stewart S, Murphy NF, Walker A, McGuire A, McMurray JJ. The current cost of angina pectoris to the National Health Service in the UK. Heart. 2003 Aug;89(8):848-53. doi: 10.1136/heart.89.8.848.

    PubMed 12860855

  • Jackson SL, Tong X, Yin X, George MG, Ritchey MD. Emergency Department, Hospital Inpatient, and Mortality Burden of Atrial Fibrillation in the United States, 2006 to 2014. Am J Cardiol. 2017 Dec 1;120(11):1966-1973. doi: 10.1016/j.amjcard.2017.08.017. Epub 2017 Aug 30.

    PubMed 28964382

  • Ptaszek LM, Baugh CW, Lubitz SA, Ruskin JN, Ha G, Forsch M, DeOliveira SA, Baig S, Heist EK, Wasfy JH, Brown DF, Biddinger PD, Raja AS, Scirica B, White BA, Mansour M. Impact of a Multidisciplinary Treatment Pathway for Atrial Fibrillation in the Emergency Department on Hospital Admissions and Length of Stay: Results of a Multi-Center Study. J Am Heart Assoc. 2019 Sep 17;8(18):e012656. doi: 10.1161/JAHA.119.012656. Epub 2019 Sep 12.

    PubMed 31510841

  • Calkins H, Hindricks G, Cappato R, Kim YH, Saad EB, Aguinaga L, Akar JG, Badhwar V, Brugada J, Camm J, Chen PS, Chen SA, Chung MK, Nielsen JC, Curtis AB, Davies DW, Day JD, d'Avila A, de Groot NMSN, Di Biase L, Duytschaever M, Edgerton JR, Ellenbogen KA, Ellinor PT, Ernst S, Fenelon G, Gerstenfeld EP, Haines DE, Haissaguerre M, Helm RH, Hylek E, Jackman WM, Jalife J, Kalman JM, Kautzner J, Kottkamp H, Kuck KH, Kumagai K, Lee R, Lewalter T, Lindsay BD, Macle L, Mansour M, Marchlinski FE, Michaud GF, Nakagawa H, Natale A, Nattel S, Okumura K, Packer D, Pokushalov E, Reynolds MR, Sanders P, Scanavacca M, Schilling R, Tondo C, Tsao HM, Verma A, Wilber DJ, Yamane T. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2017 Oct;14(10):e275-e444. doi: 10.1016/j.hrthm.2017.05.012. Epub 2017 May 12. No abstract available.

    PubMed 28506916

  • Hakalahti A, Biancari F, Nielsen JC, Raatikainen MJ. Radiofrequency ablation vs. antiarrhythmic drug therapy as first line treatment of symptomatic atrial fibrillation: systematic review and meta-analysis. Europace. 2015 Mar;17(3):370-8. doi: 10.1093/europace/euu376. Epub 2015 Feb 1.

    PubMed 25643988

  • Kuck KH, Brugada J, Furnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9;374(23):2235-45. doi: 10.1056/NEJMoa1602014. Epub 2016 Apr 4.

    PubMed 27042964

  • Chun KRJ, Brugada J, Elvan A, Geller L, Busch M, Barrera A, Schilling RJ, Reynolds MR, Hokanson RB, Holbrook R, Brown B, Schluter M, Kuck KH; FIRE AND ICE Investigators. The Impact of Cryoballoon Versus Radiofrequency Ablation for Paroxysmal Atrial Fibrillation on Healthcare Utilization and Costs: An Economic Analysis From the FIRE AND ICE Trial. J Am Heart Assoc. 2017 Jul 27;6(8):e006043. doi: 10.1161/JAHA.117.006043.

    PubMed 28751544

Questions about this trial

What is this clinical trial studying?

A study testing Ablation of atrial fibrillation (AF) in people with Atrial Fibrillation (AF), run by Asklepios proresearch at 13 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from any atrial tachyarrhythmia (time frame: within 3 to 12 months follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05294445, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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