Scientific Evidence

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Nuubo considers that cutting edge technology can only be considered as such if it also works in real life, with real patients living a normal life. That is why Nuubo is strongly focused on clinical research.
Apart from the completed and published studies, Nuubo currently has approximately 3500 patients enrolled in ongoing clinical trials, validating the Nuubo technology for real clinical use. Nuubo is conducting studies in the following areas:

- Technology validation
- Risk stratification
- Auricular Fibrillation
- QT analysis
- Cardiac Rehabilitation

The main focus of Nuubo research is Atrial Fibrillation: currently more than 2200 patients are being included in research in three areas of atrial fibrillation: After suffering an ictus of unknown origin, after undergoing pulmonary vein ablation and for screening of patients with risk of AF.

Technology validation

Arrhytmia risk stratification

Study Overview

Impact / Conclusion

Diagnostic yield of 7-day versus 21-day ECG monitoring in different groups of patients in routine clinical practice 1

Nuubo prolonged ECG monitoring was feasible and effective in routine clinical practice; quality of signal was very good and patients tolerance to use the nuubo wearable device was very high
- The conclusion highlights the higher diagnostic yield of prolonged aECG (7 and 21 days) compared with tradionational 24h holter in all types of arrhythmias

Diagnostic Yield of 7-day Versus 1-day Recordings in Hypertrophic Miocardiopathy Patients 2 Assess incidence and diagnostic yield in detection of NSVT of 7 days versus 24h and 48h ambulatory ECG monitoring by NUUBO recording in patients with HCM

- NSVT may lead SCD in some HCM patients
- Nuubo prolonged aECG for 7 days increased significantly the NSVT diagnostic yield in HCM patients. NSVT was detected in 20 patients (40%), 5 times more than the 4 patients (8%) detected in the first 24h
- These results could lead to a change in the guidelines in Risk Stratification for HCMIO for a longer monitoring period

AF prevalence in a family with mutated HCN4 gene individuals 1 Study the prevalence of Atrial Fibrillation in this population of 40 members

- ECG quality average >90% of the monitoring time with full patient compliance for a 14 day monitoring strategy
- 1 patient with asymptomatic AF was diagnosed
- Demonstrates that Nuubo is suitable for use in routine clinical practice for AF detection

1) E.T. Locati, C. Ardito, F. Cecchi, A. Testoni, F. Heilbron, M. Lunati; P5504 Diagnostic yield of 7-days versus 21-days recordings by using a new wearable wireless continuous ambulatory ECG recorder, European Heart Journal, Volume 38, Issue suppl_1, 1 August 2017, ehx493, P5504 Ver enlace

2) Poster and oral communication to be presented 24 of November at Place 2017. Prof Franco Cecchi (Rome, Italy)

AF detection after stroke of unknown origin

AF following ablation

Sports arrhythmias

Study Overview

Impact / Conclusion

Evaluation of Nuubo for Cardiac Screening in Soccer Players 1 Feasibility of Nuubo during a field stress test performed by soccer players, comparing results with treadmill ergospirometry

- The use of Nuubo’s technology allowed an accurate ECG recording and estimation of reliable performance variables during exercise testing
- Nuubo provides a new perspective to cardiac remote monitoring in sports

Usefulness of Nuubo for the screening of potentially malign ECG patterns during sport practice 2 Analyze the effectiveness of Nuubo for screening potentially lethal ECG patterns during exercise

- Nuubo monitoring could be a useful tool in studying athletes during sports

1) Fabregat-Andres, Oscar, Adolfo Munoz-Macho, Guillermo Adell-Beltran, Xavier Ibanez- Catala, Agustin Macia, & Lorenzo Facila."Evaluation of a New Shirt-Based Electrocardiogram Device for Cardiac Screening in Soccer Players: Comparative Study With Treadmill Ergospirometry."Cardiology Research [Online], 5.3-4 (2014): 101-107.

2) 6044-593 -Utilidad Del Sistema Necg Dynamic Platform (Nuubo) Para El Screening De Patrones Electrocardiográficos Potencialmente Malignos Durante La Práctica Deportiva.Rev Esp Cardiol. 2014;67 Supl 1:932

Wearcare – cardiac rehabilitation

Study Overview

Impact / Conclusion

Use of Nuubo in a pilot study in cardiac rehabilitation 1 Test the effectiveness and applicability in the area of health care for ischemic heart disease population with Nuubo

- Nuubo simplifies the cumbersome traditional methods of connecting electrodes for the user
- Signal quality was very good
- This study validated Nuubo for use in cardiac rehabilitation

Effectiveness of a home RC program with Nuubo in ischemic patients 2 Assess the effectiveness and security of a home RC program with mixed supervision in patients with ischemic cardiomyopathy and moderate risk

- Home RC program with mixed supervision showed that Nuubo is as effective and safe as the current on-site model in moderate risk patients with ischemic cardiomyopathy
- Results show that Nuubo can be a helpful tool for home monitoring of chronic cardiovascular patients

Preliminary Results of a Trimodal Prehabilitation Program In Patients Awaiting Cardiac Surgery 3 Prehabilitation Unit incorporated patients awaiting for cardiac surgery to the already running program, mainly focused on major abdominal surgery

- Excellent patient compliance
- Nuubo recorded an VT in one patient during home based exercise
- Results could open a door to Nuubo in prehabilitation units

1) Álvarez Leiva, M. Isabel, et al."Pilotaje de un dispositivo de monitorización cardiaca remota."Metas de Enfermería 16.5 (2013): 12-17.

2) Bravo-Escobar, Raquel, et al."Effectiveness and safety of a home-based cardiac rehabilitation programme of mixed surveillance in patients with ischemic heart disease at moderate cardiovascular risk: A randomised, controlled clinical trial."BMC cardiovascular disorders 17.1 (2017): 66.

3) Bofill, A. et al. “IMPLEMENTATION OF A TRIMODAL PREHABILITATION PROGRAM IN PATIENTS AWAITING CARDIAC SURGERY. PRELIMINARY RESULTS”. Poster in Surgical Prehabilitation to Improve Postoperative Outcome Congress, 2017