Stroke Prevention and Rhythm Control Therapy STEEER-AF

Atrial Fibrillation Clinical Trial

— STEEER-AF  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04396418
• Other study ID #: STEEER-AF
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 29, 2021
• Est. completion date: December 30, 2025

Study information

• Verified date: June 2024
• Source: European Society of Cardiology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1732
• Est. completion date: December 30, 2025
• Est. primary completion date: January 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with AF

• Patient consents to data collection at baseline and follow-up.

Exclusion Criteria (patients only):

• 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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Behavioral:
• Education
Randomization between two groups at site level. One cluster with education and one without.

Locations

Country	Name	City	State
France	CHU Aix en Provence	Aix en Provence	Provence-Alpes-Côte d'Azur
France	Hôpital Henri Mondor (APHP)	Créteil	Île-de-France
France	CHU Dijon - Hôpital du Bocage	Dijon	Burgundy
France	CHU Dupuytren	Limoges	Haute-Vienne
France	CHU La Timone	Marseille	Bouches-du-Rhône
France	CHU Nancy, Hôpitaux de Brabois	Nancy	Meurthe-et-Moselle (Lorraine)
France	CHU Pitié-Salpetrière	Paris	Ile De France
France	Centre Hospitalier de Pau	Pau	Pyrénées-Atlantiques
France	Hôpital Cardiologique du Haut-Lévèque	Pessac	Gironde, Nouvelle-Aquitaine
France	CHU Poitiers	Poitiers	Poitou-Charentes
France	CHU Rennes	Rennes	'Ille-et-Vilaine, Brittany
France	CHU Rouen	Rouen	Normandy
France	Centre Cardiologique du Nord (CCN)	Saint-Denis	Ile De France
France	CHI Toulon La Seyne-sur-Mer Sainte Musse	Toulon	Var
France	CHU Rangueil	Toulouse	Occitanie, Haute-Garonne
Germany	Segeberger Kliniken GmbH	Bad Segeberg	chleswig-Holstein
Germany	Praxisklinik Herz Und Gefässe	Dresden	Saxony
Germany	Asklepios Klinik St. Georg	Hamburg
Germany	Heart Center University Hamburg	Hamburg
Germany	Medizinische Hochschule Hannover, MHH	Hannover
Germany	Herzzentrum Niederrhein Krefeld	Krefeld	North Rhine-Westphalia
Germany	Heart Center Leipzig, University of Leipzig	Leipzig	Saxony
Germany	Universitätsklinikum Schleswig-Holstein Lübeck	Lübeck
Germany	Heart Centre Bad Neustadt	Neustadt	Rhineland-Palatinate
Germany	Herz Riesa	Riesa	Saxony
Germany	University Hospital Würzburg	Würzburg	Bavaria
Italy	Clinica Aritmologica, Universita Politecnica delle Marche	Ancona
Italy	S Orsola-Malpighi University Hospital	Bologna	Emilia-Romagna
Italy	Sant'Anna University Hospital of Ferrara	Ferrara	Emilia-Romagna
Italy	Cardiology Unit Borgo San Lorenzo and Serristori	Florence
Italy	University of Florence & AOU Careggi	Florence	Tuscany
Italy	Policlinico di Modena, University of Modena and Reggio Emilia	Modena	Emilia-Romagna
Italy	Federico II University Hospital	Naples	Campania
Italy	Cardiologia Orvieto	Orvieto	Terni
Poland	District Chojnice Hospital	Chojnice
Poland	Scanmed Cardiology Center	Elk
Poland	Centrum Opieki Medycznej w Jaroslawiu	Jaroslaw
Poland	Poliklinika SPZOZ w Lublinie	Lublin
Poland	Lukow	Lukow
Poland	Przasnysz	Przasnysz
Poland	Pultusk	Pultusk
Poland	Siedlce 2 Hospital	Siedlce
Poland	Wojewódzki Szpital Specjalistyczny nr 5 im	Sosnowiec
Poland	Szpital Wojewodzki in Sw. Lukasza / Regional Specialist Hospital	Tarnow
Poland	Torun Hospital	Torun	Vistula Rive
Poland	Wegrow Hospital	Wegrow
Spain	Hospital General Universitario de Alicante	Alicante	Valencian
Spain	Hospital Germans Trias i Pujol	Barcelona	Catalonia
Spain	Hospital Universitari de Bellvitge	Barcelona	Catalonia
Spain	Hospital Vall d'Hebron	Barcelona	Catalonia
Spain	Hospital Universitari Doctor Josep Trueta	Girona	Catalonia
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Puerta del Mar	Sevilla	Andalusia
Spain	Virgen del Rocio University Hospital	Sevilla	Andalucía
Spain	Hospital La Fe.com.Valencianna	Valencia
Spain	Hospital Gral Vigo, Galicia	Vigo
Spain	Hospital Miguel Servet	Zaragoza	Aragon
United Kingdom	Horton General Hospital	Banbury	River Cherwell In Oxfordshire
United Kingdom	Queen Elizabeth II	Birmingham
United Kingdom	Buckinghamshire Healthcare NHS Trust - Wycombe Hospital	Buckingham	Buckinghamshire
United Kingdom	Royal Devon and Exeter NHS Foundation Trust	Exeter	West England
United Kingdom	Gloucestershire Royal Hospital	Gloucester	England
United Kingdom	Homerton Hospital	London	England
United Kingdom	Imperial College London Chelsea and Westminster Hospital NHS foundation	London	England
United Kingdom	St Bartholomew's Hospital	London	England
United Kingdom	James Cook University Hospital	Middlesborough	England
United Kingdom	Northampton General Hospital	Northampton	England
United Kingdom	Norwich Hospital	Norwich	East Of England
United Kingdom	Royal Berkshire foundation NHS trust	Reading	England
United Kingdom	York Hospital	York	North Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
European Society of Cardiology	University of Birmingham

Countries where clinical trial is conducted

France,  Germany,  Italy,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Process outcome	Improvement in knowledge and guideline-adherent practice by healthcare professionals using the educational intervention	25 months per centre
Primary	Adherence to ESC Guidelines in Atrial Filbrillation	Full adherence to guidelines for stroke prevention rhythm control therapy	25 months per centre
Secondary	Proportion of relevant guidelines adhered to	Proportion of relevant guidelines adhered to for stroke prevention and rhythm control	25 months per centre