International research project to quantify atrial fibrillation burden and develop uniform standards for medical devices and wearables

AF-B-STEP (Kompetenznetz Vorhofflimmern e.V.)

Münster · Hamburg · Maastricht (NL)New on Amplifa

2026Project start

18Partners from Europe and Canada

ca. 18 Mio. €Funding budget over 4 years (IHI)

>100.000Data records analyzed

VR 5003, Amtsgericht MünsterRegister (Kompetenznetz Vorhofflimmern e.V.)

About the project

AF-B-STEP is an international research project to quantify atrial fibrillation burden. For the first time, the project systematically records how long atrial fibrillation persists in individual patients and investigates how this burden affects the risk of stroke, heart failure and other health consequences as well as quality of life. To this end, the consortium of 18 partners from Europe and Canada – including university hospitals, industrial companies, patient organizations and payers – analyzes data from more than 100,000 individuals and develops uniform standards for how medical devices, from implantable cardiac devices to ECG patches, as well as wearables such as smartwatches should measure and report atrial fibrillation. The goal is three defined AF burden categories (low/medium/high) that support clinical treatment decisions as well as European regulation and innovation. The project is funded over approximately four years with around 18 million euros by the Innovative Health Initiative (IHI) and is coordinated by the Department of Cardiology of the University Heart and Vascular Center UKE Hamburg and the Medtronic Bakken Research Center in Maastricht. The AFNET office in Münster is hosted by the Competence Network Atrial Fibrillation e.V. (AFNET).

Site: Münster
Processes: Quantification of atrial fibrillation burden (AF burden), Development of uniform standards for medical devices and wearables, Analysis of data from over 100,000 individuals, Definition of AF burden categories (low/medium/high)
Materials: Atrial fibrillation burden, Cardiac pacemakers and implantable event recorders, Consumer wearables (smartwatches, fitness trackers, ECG patches), Patient-relevant endpoints
Industries: Cardiology / Cardiac arrhythmias, Medical technology, Wearables / Consumer electronics, Healthcare / Health policy

01
Data collection and data integration (over 100,000 individuals)
02
Analysis of atrial fibrillation burden and its impact
03
Definition of AF burden categories
04
Validation based on clinical studies
05
Development of uniform standards for devices and wearables
06
Derivation of recommendations for clinical practice and health policy

Methods and data sources

AF-Burden

Atrial fibrillation burden

Time spent in atrial fibrillation, basis for low/medium/high categories for treatment decisions.

CIED

Cardiac pacemakers and implantable event recorders

Data source for continuous rhythm monitoring, for which uniform reporting standards are being developed.

Wearable

Consumer wearables (smartwatches, fitness trackers, ECG patches)

Devices whose AF detection and data reporting are to be standardized.

Outcome-Data

Patient-relevant endpoints

Stroke, heart failure, cardiovascular death, quality of life as well as cardiac and brain function.

Locations

Münster

Office of the Competence Network Atrial Fibrillation e.V. (AFNET)

Hamburg

Project coordination, Department of Cardiology, University Heart and Vascular Center UKE

Maastricht

Industry project lead, Medtronic Bakken Research Center

Research subjects

**Visualization of atrial fibrillation burden**Data analysis · Cardiology

Inside the production

Logo of the Innovative Health Initiative (IHI) as funding body

Industries

Cardiology / Cardiac arrhythmiasMedical technologyWearables / Consumer electronicsHealthcare / Health policy

Additional services

Quantification of atrial fibrillation burden (AF burden)Development of uniform standards for medical devices and wearablesAnalysis of data from over 100,000 individualsDefinition of AF burden categories (low/medium/high)

Reference customers

Innovative Health Initiative (IHI) – funding body (EU and industry)

History

2026
Start of the international research project AF-B-STEP with 18 partners from Europe and Canada; funding over approx. 4 years with around €18 million by the Innovative Health Initiative (IHI)
2026
Press releases on 04.02.2026 by AFNET, ESC and idw
2026
Participation in the ESC Congress 2026 in Munich (30.08.); first patient event at University Hospital Cologne (26.11.)