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Smart ICT-solution to cost-efficiently detect atrial fibrillation to Reduce Europe’s burden of Stroke

Periodic Reporting for period 1 - RedStroke (Smart ICT-solution to cost-efficiently detect atrial fibrillation to Reduce Europe’s burden of Stroke)

Reporting period: 2018-11-01 to 2019-10-31

Nine out of ten strokes can be prevented. Measuring cardiac rhythm regularly helps.
Stroke is the second most common cause of death, with 1 million deaths in Europe each year. Stroke survivors are often faced with complex disabilities associated with high health care costs (~€64 billion each year in Europe). The main risk factors for stroke include atrial fibrillation (AF), the most common type of sustained cardiac arrhythmia. AF may come and go, and is often not noticed. Its sporadic occurrence is the main reason why it is so difficult to capture. Chances to detect AF with „classic” methods (in office electrocardiogram [ECG] and 24 hour-Holter-ECG) are less than 20%. Furthermore, these methods are costly and not suitable for routine AF screening of large populations. The German SME company Preventicus develops innovative smart health technologies for AF screening with ECG-comparable accuracy – instantly and with a smartphone only. Positive AF cases are verified by Telecare services, followed by a new 14days Holter-ECG-Patch service (for AF confirmation) on demand. Upon early AF diagnosis, therapy can be initiated that prevents strokes. Smart AF detection solutions are a major step forward towards reducing the burden of stroke in Europe.
The overall objective of the RedStroke project is to identify AF earlier and more often than is currently the case in Europe by Standard of Care. For people across Europe to benefit from Preventicus smartphone based AF detection solutions Preventicus needs to analyze and assess various countries and markets in the EU to prepare and implement these solutions in selected countries and subsequently across the entire EU. The result will be the availability of Preventicus solutions across the EU, the reduction of strokes in the EU, and a sustainable business model for Preventicus and cooperating parties, and highly interesting employment opportunities.
This report covers work performed between November 1st, 2018 and October 31st, 2019. The main results achieved so far are:

• Evaluation of selected European Markets resulted in 8 target countries:
Germany, Austria, Switzerland, UK, Spain, France, Poland, Netherlands

• Development of Preventicus Managed Care Program (AF Screening and AF Confirmation) in 6 steps:
1) Smartphone AF Screening
2) Telecare Quality Control and Verification
3) Referral to local Cardiologist
4) ECG Patch for AF Confirmation (14 days)
5) Telecare Quality Control, Verification and Report Summary
6) Diagnosis through local Cardiologist

• Composing a special care contract according to SGB V §140a for Germany
- Contract was signed in July 2018
- >10 public health insurers are preparing a rollout in different regions of Germany
- considering all legal, data processing and data security issues
- supported by association of Resident Cardiologists in Germany (BNK e.V.)
- groundwork for implementation in selected EU target countries

• Health Economic Evaluation of Preventicus Managed Care Program is showing positive results compared to Standard of Care (Germany)
- Preventicus Managed Care reduces number of strokes
- Preventicus Managed Care reduces health care cost
- Bbasis for economic evaluation in selected EU target countries

• Telecare-Center Ulm GmbH is the major Telecare Centre starting in Germany

• Successful Development and Testing of Electronic Invoicing in Preventicus managed Care Program

• Data Safety and Data Security Concept established

• Implementation of Carenet and CareSafe software platforms

• Preperation and Start of the RedStroke Clinical Study
- Study protocol, Ethics Approval, Patient Information and Consent
- 7 participating study centers (Basel/CH, Maastricht/NL, Birmingham/UK, Belgrade/SRB, Greifswald/GER, Krakow/PL, Athens/GRE)
"By successfully executing the RedStroke project we expect across the EU by the year 2025:

• 750,000 participants in Preventicus AF Screening
• 30,000 newly identified and confirmed AF cases
• 5,000 avoided strokes (and associated deaths and disabilities)
• Significant Healthcare Cost Reduction because of avoided strokes
(>100,000,000€ - 200,000,000€)
• Increased awareness on cardiac health and stroke risks
• Greater Patient Empowerment and Health Literacy
• Sustainable and Scalable Business Model for Preventicus and its cooperating partners
• Significant Growth of Preventicus as a Company (including # of employees)"
Development of Preventicus Managed Care Program (AF Screening and AF Confirmation) in 6 steps