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Atrial FibrillationSTEEER-AFNCT04396418

Stroke Prevention and Rhythm Control Therapy STEEER-AF

A study testing Education in people with Atrial Fibrillation, run by European Society of Cardiology at 70 sites in 6 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A prospective trial with hospitals/health centres across 6 different European countries, being randomised to either a structured education programme as the intervention or no additional education as the control. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,732 participants
Where
70 sitesin 6 countries
Study dates
29 Dec 2021to 30 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

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

  • Patients diagnosed with AF
  • Patient consents to data collection at baseline and follow-up.

Who cannot join

  • Patients aged under 18 years of age,
  • Pregnant or planning pregnancy,
  • Participating in another clinical trial of an investigational medicinal product or device,
  • Life expectancy of less than 2 years.
  • Patient assessment: Baseline (time of recruitment) and at follow-up routine appointment (6-9 months), plus remote follow-up at 18 months.

Trial locations and contacts

70 sites in 6 countries.

70 sites in 6 countries

France15 sites

  • CHU Aix en Provence

    Aix-en-Provence, Provence-Alpes-Côte d'Azur Region, 13100

  • Hôpital Henri Mondor (APHP)

    Créteil, Île-de-France Region, 94000

  • CHU Dijon - Hôpital du Bocage

    Dijon, Burgundy, 21000

  • CHU Dupuytren

    Limoges, Haute-Vienne, 87000

  • CHU La Timone

    Marseille, Bouches-du-Rhône, 13005

  • CHU Nancy, Hôpitaux de Brabois

    Nancy, Meurthe-et-Moselle (Lorraine), 54500

  • CHU Pitié-Salpetrière

    Paris, Île-de-France Region, 75013

  • Centre Hospitalier de Pau

    Pau, Pyrénées-Atlantiques, 64046

  • Hôpital Cardiologique du Haut-Lévèque

    Pessac, Gironde, Nouvelle-Aquitaine, 33600

  • CHU Poitiers

    Poitiers, Poitou-Charentes, 86000

  • CHU Rennes

    Rennes, 'Ille-et-Vilaine, Brittany, 35000

  • CHU Rouen

    Rouen, Normandy, 76000

  • Centre Cardiologique du Nord (CCN)

    Saint-Denis, Île-de-France Region, 93200

  • CHI Toulon La Seyne-sur-Mer Sainte Musse

    Toulon, Var, 83100

  • CHU Rangueil

    Toulouse, Occitanie, Haute-Garonne, 31400

Other trials in France

United Kingdom13 sites

  • Horton General Hospital

    Banbury, River Cherwell in Oxfordshire, OX16

  • Queen Elizabeth II

    Birmingham

  • Buckinghamshire Healthcare NHS Trust - Wycombe Hospital

    Buckingham, Buckinghamshire, HP11 2TT

  • Royal Devon and Exeter NHS Foundation Trust

    Exeter, West England, 01392

  • Gloucestershire Royal Hospital

    Gloucester, England, GL1 3NN

  • Homerton Hospital

    London, England, E9 6SR

  • St Bartholomew's Hospital

    London, England, EC1A 7BE

  • Imperial College London Chelsea and Westminster Hospital NHS foundation

    London, England, SW10 9NH

  • James Cook University Hospital

    Middlesbrough, England, TS4 3BW

  • Northampton General Hospital

    Northampton, England, NN1 5BD

  • Norwich Hospital

    Norwich, East of England, NR1-NR16

  • Royal Berkshire foundation NHS trust

    Reading, England, RG1 5AN

  • York Hospital

    York, North Yorkshire, YO31 8H

Other trials in United Kingdom

Poland12 sites

  • District Chojnice Hospital

    Chojnice, 89-600

  • Scanmed Cardiology Center

    Ełk, 19-302.

  • Centrum Opieki Medycznej w Jaroslawiu

    Jarosław, 37-500

  • Polikliniką SPZOZ w Lublinie

    Lublin, 20-400

  • Lukow

    Łuków, 21-400

  • Przasnysz

    Przasnysz, 06-300

  • Pułtusk

    Pułtusk, 06-100

  • Siedlce 2 Hospital

    Siedlce, 08-119

  • Wojewódzki Szpital Specjalistyczny nr 5 im

    Sosnowiec, 41-200

  • Szpital Wojewodzki in Sw. Lukasza / Regional Specialist Hospital

    Tarnów, 33-100

  • Toruń Hospital

    Torun, Vistula Rive, 87-100

  • Wegrow Hospital

    Węgrów, 07-100

Other trials in Poland

Germany11 sites

  • Segeberger Kliniken GmbH

    Bad Segeberg, chleswig-Holstein, 23795

  • Praxisklinik Herz Und Gefässe

    Dresden, Saxony, 01099

  • Asklepios Klinik St. Georg

    Hamburg, 20099

  • Heart Center University Hamburg

    Hamburg, 20251

  • Medizinische Hochschule Hannover, MHH

    Hanover, 30159

  • Herzzentrum Niederrhein Krefeld

    Krefeld, North Rhine-Westphalia, 47805

  • Heart Center Leipzig, University of Leipzig

    Leipzig, Saxony, 04289

  • Universitätsklinikum Schleswig-Holstein Lübeck

    Lübeck, 23562

  • Heart Centre Bad Neustadt

    Neustadt, Rhineland-Palatinate, 97616

  • Herz Riesa

    Riesa, Saxony, 01587

  • University Hospital Würzburg

    Würzburg, Bavaria, 97080

Other trials in Germany

Spain11 sites

  • Hospital General Universitario de Alicante

    Alicante, Valencian, 03010

  • Hospital Vall d'Hebron

    Barcelona, Catalonia, 08035

  • Hospital Universitari de Bellvitge

    Barcelona, Catalonia, 08907

  • Hospital Germans Trias i Pujol

    Barcelona, Catalonia, 08916

  • Hospital Universitari Doctor Josep Trueta

    Girona, Catalonia, 17007

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Puerta del Mar

    Seville, Andalusia, 11009

  • Virgen del Rocio University Hospital

    Seville, Andalusia, 41013

  • Hospital La Fe.com.Valencianna

    Valencia, 46026

  • Hospital Gral Vigo, Galicia

    Vigo

  • Hospital Miguel Servet

    Zaragoza, Aragon, 50009

Other trials in Spain

Italy8 sites

  • Clinica Aritmologica, Universita Politecnica delle Marche

    Ancona, 60100

  • S Orsola-Malpighi University Hospital

    Bologna, Emilia-Romagna, 40138

  • Sant'Anna University Hospital of Ferrara

    Ferrara, Emilia-Romagna, 44100

  • University of Florence & AOU Careggi

    Florence, Tuscany, 50121

  • Cardiology Unit Borgo San Lorenzo and Serristori

    Florence

  • Policlinico di Modena, University of Modena and Reggio Emilia

    Modena, Emilia-Romagna, 41100

  • Federico II University Hospital

    Naples, Campania, 80138

  • Cardiologia Orvieto

    Orvieto, Terni, 05018

Other trials in Italy

About this study

Official title: Stroke Prevention and Rhythm Control Therapy: Evaluation of an Educational Programme of the European Society of Cardiology in a Cluster-Randomised Trial in Patients With Atrial Fibrillation

A prospective trial with hospitals/health centres across 6 different European countries, being randomised to either a structured education programme as the intervention or no additional education as the control. To determine whether a comprehensive educational programme for healthcare professionals will increase the rate of appropriate stroke prevention and rhythm control therapy in patients with atrial fibrillation (AF) and adherence to Guidelines.

Read the detailed description

Prospective, parallel group, two-arm, unblinded, international, cluster-randomized controlled trial.

Intervention arm: A 16-week blended learning programme targeting stroke prevention and rhythm control therapy at the healthcare professional level, with controlled assessments, a commitment to change plan, and reinforcement actions Control arm: No added education of healthcare professionals 70 centres with a cluster size of 25 patients; total estimated number of patients 1750.

8-12 weeks patient recruitment period at each centre; 16 weeks educational intervention period; primary \& secondary outcomes at 6-9 months post-randomisation; remote follow-up for clinical events (no new patient contact) at 18 months from randomisation.

Being tested
Education
Keywords
Atrial fibrillation, Guideline adherence, stroke prevention, rhythm control, trial
Medical subject headings
Atrial Fibrillation

What participants receive

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

  • EducationBehavioural

    Randomization between two groups at site level. One cluster with education and one without.

Study groups in NCT04396418
Study groupRoleWhat they receive
Intervention armExperimentalA 16-week blended learning programme targeting stroke prevention and rhythm control therapy at the healthcare professional level, with controlled assessments, a commitment to change plan, and reinforcement actions
Receives: Behavioral: Education
Control armOtherNo added education of healthcare professionals
Receives: Behavioral: Education

What is being measured

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

  1. Adherence to ESC Guidelines in Atrial Filbrillation

    Full adherence to guidelines for stroke prevention rhythm control therapy

    Measured: 25 months per centre

Secondary outcomes (1)

  1. Proportion of relevant guidelines adhered to

    Proportion of relevant guidelines adhered to for stroke prevention and rhythm control

    Measured: 25 months per centre

Timeline

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

  1. First posted20 May 2020
  2. Study start29 Dec 2021
  3. Primary completion10 Jan 2024
  4. Study completion30 Dec 2025 (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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
1,732 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04396418
Sponsor's protocol ID
STEEER-AF
Acronym
STEEER-AF
Status last verified
Jun 2024
First submitted
14 May 2020
Last updated
20 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kotecha D, Bunting KV, Mehta S, Sommer P, Sterlinski M, Rajappan K, Mont L, Guasch E, Boveda S, Boriani G, Sun Y, van Deutekom C, Gale CP, De Potter TJR, van Gelder IC; STEEER-AF investigators. Education of healthcare professionals to improve guideline adherence in atrial fibrillation: the STEEER-AF cluster-randomized clinical trial. Nat Med. 2025 Aug;31(8):2647-2654. doi: 10.1038/s41591-025-03751-2. Epub 2025 Jun 13.

    PubMed 40514462

  • Sterlinski M, Bunting KV, Boriani G, Boveda S, Guasch E, Mont L, Rajappan K, Sommer P, Mehta S, Sun Y, Gale CP, van Deutekom C, Van Gelder IC, Kotecha D; STEEER-AF Trial Team. Design and deployment of the STEEER-AF trial to evaluate and improve guideline adherence: a cluster-randomized trial by the European Society of Cardiology and European Heart Rhythm Association. Europace. 2024 Jul 2;26(7):euae178. doi: 10.1093/europace/euae178.

    PubMed 38940494

  • Szymanski P, Weidinger F, Lordereau-Richard I, Himmelmann A, Arca M, Chaves J, Lee C, Jonker C, Kotecha D, O'Kelly J, Plueschke K, Rys A, Segec A, Wallentin L, Veltrop R, James S. Real world evidence: Perspectives from a European Society of Cardiology Cardiovascular Round Table with contribution from the European Medicines Agency. Eur Heart J Qual Care Clin Outcomes. 2023 Feb 28;9(2):109-118. doi: 10.1093/ehjqcco/qcad009.

    PubMed 36746430

  • Banerjee A, Pasea L, Chung SC, Direk K, Asselbergs FW, Grobbee DE, Kotecha D, Anker SD, Dyszynski T, Tyl B, Denaxas S, Lumbers RT, Hemingway H. A population-based study of 92 clinically recognized risk factors for heart failure: co-occurrence, prognosis and preventive potential. Eur J Heart Fail. 2022 Mar;24(3):466-480. doi: 10.1002/ejhf.2417. Epub 2022 Jan 26.

    PubMed 34969173

Questions about this trial

What is this clinical trial studying?

A study testing Education in people with Atrial Fibrillation, run by European Society of Cardiology at 70 sites in 6 countries.

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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in France, United Kingdom, Poland, Germany, Spain and 1 more country. 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?

Results are not available in the source record.

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?

Adherence to ESC Guidelines in Atrial Filbrillation (time frame: 25 months per centre). 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 NCT04396418, which also lists 4 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 Jun 2024.

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