Evidence

Proven clinical evidence. Proven cost-effectiveness.

Facts and studies

From the first concept to the evaluation and continuous refinement, Preventicus has been working closely with cardiologists, scientists, engineers, patients, and population health experts. For us, the guiding principle has always been on matching medical knowledge with what digital technologies offer today.

Scientific research demonstrates the legitimacy of the use of the Preventicus® Heartbeats App and Preventicus Nightwatch® for stroke prevention. In the most recent international studies on over 1,300 participants (Watch AF and Detect AF Pro), it was shown that the app detected atrial fibrillation (AF) with an accuracy of approx. 96%. The positive predictive value was over 99%, which means that two independent cardiologists subsequently confirmed AF recognized by the Preventicus Heartbeats App in over 99% of the cases.

Results of the most recent scientific studies published:

The WATCH AF Trial: SmartWATCHes for Detection of Atrial Fibrillation

M. Dörr, V. Nohturfft et al. The WATCH AF Trial: SmartWATCHes for Detection of Atrial Fibrillation.
JACC: Clinical Electrophysiology. November 2018.
DOI: 10.1016/j.jacep.2018.10.006
ClinicalTrials.gov Identifier: NCT02956343

It is the world’s first international, prospective, double-blinded and multicenter clinical trial (ClinicalTrials.gov ID: NCT02956343) evaluating the accuracy of a smartwatch to detect atrial fibrillation. Preventicus provided the application for blinded analysis of 1 minute plethysmographic raw data (recorded with pulse sensor of Samsung Gear Fit II smartwatch) of 636 study participants. Total accuracy of the application was 96.2% with a positive predictive value of 97.4% in comparison to the ECG based diagnosis of two cardiologists.

Detection of atrial fibrillation with a smartphone camera: first prospective, international, two-center, clinical validation study (DETECT AF PRO)

N. Brasier, C. J. Raichle, M. Dörr, A. Becke, V. Nohturfft, S. Weber, F. Bulacher, L. Salomon, T. Noah, R. Birkemeyer, J. Eckstein. Detection of atrial fibrillation with a smartphone camera: first prospective, international, two-centre, clinical validation study (DETECT AF PRO). EP Europace, , euy176, https://doi.org/10.1093/europace/euy176
ClinicalTrials.gov Identifier: NCT02270112

The AF detection algorithm available in the smartphone camera application (“Preventicus Heartbeats”) has been tested in the DETECT AF PRO trial (ClinicalTrials.gov ID: NCT02949180); a prospective, double-blinded, international multicenter study with 672 participants. Total accuracy of the smartphone camera application to detect AF was 96.5% with a positive predictive value of 99.3% compared to the ECG based diagnosis of two cardiologists by mutual agreement.

AF detection using smartphone apps

N. Karim, M. Aral et al. AF detection using smartphone apps. EP Europace, Volume 19, Issue suppl_3, 1 June 2017, Pages iii234 https://doi.org/10.1093/ehjci/eux151.246

To determine whether smartphone apps that require no additional peripheral devices are sufficiently accurate to screen populations for atrial fibrillation (AF), the authors prospectively and blinded analyzed smartphone apps, e.g. Preventicus Heartbeats utilizing the camera function in comparison to cardiologists AF diagnosis based on ECG. 140 in- and outpatients recruited with AF and sinus rhythm (n=70, 73±12 mean age, 60% male and n=70, 59±20, 66% respectively) were administered a 12-lead ECG along with a questionnaire on their smartphone use. The sensitivity and specificity of Preventicus was 94% and 96% respectively.

Detection of premature beats using smartphone-based pulse wave recordings

S. Weber, J. Eckstein et al. Detection of premature beats using smartphone-based pulse wave recordings. EP Europace, Volume 19, Issue suppl_3, 1 June 2017, Pages iii347, https://doi.org/10.1093/ehjci/eux158.243

To detect premature beats when they actually occur, the authors aimed to determine how accurate this is possible with pulse waves captured with a smartphone camera. ECG and pulse wave recordings were taken in 46 patients simultaneously. In total 17,416 beats have been analyzed and classified by ECG based decision of a cardiologist: 16,875 regular beats and 541 irregular (premature beats. Detection of premature beats with the pulse wave algorithm achieved an overall accuracy of 99.5% (sensitivity 91.2%, specificity 99.7%) compared to cardiologists’ decision based on ECG.

Smart detection of atrial fibrillation

L. Krivoshei, S. Weber et al. Smart detection of atrial fibrillation. EP Europace, Volume 19, Issue 5, 1 May 2017. https://www.ncbi.nlm.nih.gov/pubmed/27371660

A novel app using the camera sensor of an iPhone 4S with integrated LED, the researchers tested pulse wave signals acquired from the fingertips of 80 patients with atrial fibrillation (AF) (n=40) and in sinus rhythm (SR) (n=40). They aimed to test the app’s accuracy in detecting AF compared to cardiologists AF decision based on ECG. Conclusion: app reliably discriminated between SR and AF, best parameter set achieved an overall accuracy of 95% (sensitivity 95%, specificity 95%).

Validation of a New Heart Rate Measurement Algorithm for Fingertip Recording of Video Signals with Smartphones

N. Koenig, A. Seeck et al. Validation of a new heart rate measurement algorithm for fingertip recording of video signals with smartphones. Telemed J E Health. 2016 Aug;22(8):631-6. https://www.ncbi.nlm.nih.gov/pubmed/26938673

This German and Swiss team of investigators used an algorithm they developed to measure heart rate (HR). Detection of the steepest slope of every pulse wave is combined and correlated to an optimized pulse wave pattern. In 68 subjects, the pulse curves were recorded as video signals with an Apple iPhone 4S and simultaneously by ECG. The smartphone-measured HR proved extremely consistent (R > 0.99) with ECGs. Most standard linear HRV parameters also showed high correlations of R ≥ 0.90. Overall, HR and HRV captured by smartphone as video signals with the algorithm proved accurate for preclinical cardiac screening.

Cutting-edge research projects by the European Union

Preventicus is supported by two of the European Union's Horizon 2020 research projects (SME Instruments Phase II and Eurostars). Horizon 2020 is the European Union's framework program for research and innovation. This funding program aims to build an EU-wide association built on science and innovation and a competitive economy and, at the same time, contribute to sustainable development. The Horizon 2020 funding project (SME Instruments Phase II) "RedStroke" (Reducing Stroke in Europe) enables Europe-wide clinical studies based on Preventicus technology.

RedStroke - Reducing Europe's Stroke Incidence: Highly Cost-effective Population Screening Programs for Atrial Fibrillation Coupled With High Diagnostic Yield Confirmation Services

The RedStroke study is currently being conducted in seven European countries (estimated study completion date: Dec. 31, 2020). In this study, the effect of a smartphone application in detecting AF will be assessed in a double-blind randomized controlled multicenter trial.

For full details, please see https://clinicaltrials.gov/ct2/show/NCT04108884.

Economic impact

The Managed Care model was assessed from a health-economic perspective: the analysis revealed the positive cost-effectiveness within approximately three years for statutory health insurance providers in Germany. For private health insurance companies, this can be achieved within approximately five years. Please note that Germany is the most complex payor market in the European Union.

Study

A cost-effectiveness analysis model of Preventicus atrial fibrillation screening from the point of view of statutory health insurance in Germany

R. Birkemeyer, A. Müller, S. Wahler, J.-M. Graf von der Schulenburg

Download PDF

App as a certified medical device

The Preventicus Heartbeats App is a CE-marked medical device application (class IIa) complying with the essential requirements of the Medical Device Directives (MDD). Clinically validated, the app has the world's highest accuracy in the detection of AF.

Thousands of correctly conducted heart rhythm analyses daily confirm the precision of Preventicus’ superior biosignal-analytic algorithms. Preventicus has ISO 13485 certification – the design, production, installation, and servicing of our medical-grade app meet the highest quality standards. ISO also testifies to continual improvement of our solutions and procedures.