Para Nuubo, la tecnología solo es puntera si demuestra serlo en la vida real, con pacientes reales haciendo vida normal. Por ello Nuubo está fuertemente enfocada a la investigación clínica.
A parte de los estudios terminados y publicados, en este momento Nuubo posee cerca de 3500 pacientes enrolados en estudios clínicos en marcha, validando cada posible uso de la tecnología Nuubo en la clínica real. Nuubo está realizando estudios en las siguiente áreas:

- Validación tecnología
- Estratificación de Riesgo
- Fibrilación Auricular
- Uso pediátrico
- Análisis del QT
- Rehabilitación Cardiaca

El foco principal de la investigación de Nuubo es la Fibrilación Auricular, actualmente más de 2200 pacientes están siendo incluidos en investigaciones en tres entornos de la Fibrilación Auricular: Tras padecer un Ictus de origen desconocido, tras ser sometidos a ablación de venas pulmonares y para selección de pacientes con riesgo de FA.


Validación de la tecnología

Non inferiority studies to prove the ECG quality signal and patient comfort


Study Overview
Impact / Conclusion
Nuubo validation against a treadmill test: A Feasibility Study 1
- Nuubo’s first clinical study
- Proves that the Nuubo ECG is high quality and can make an ECG diagnosis
Nuubo validation against a tilt-test 2
Study to demonstrate that Nuubo can obtain similar results than a tilt-test, therefore making it a suitable technology to diagnose syncopes
Nuubo AF detection performance against pacemaker and other monitoring strategies Compared the diagnostic accuracy of the ZIO-Xt, Bardy and Nuubo to the R-test (standard clinical practice in that hospital) in detection of AF burden during 15 days of monitoring Status: patient inclusion finished, currently on statistical analysis Finished; Pending publication
- Nuubo is NOT inferior to other new technologies for AF detection (all of them superior to the R-Test) but Nuubo is the only technology that allows for up to 30 days of monitoring
- Nuubo is the most cost effective technology for long-term monitoring
Biomedical shirt-based ECG monitoring in relevant clinical situations: ECG-shirt study
Study aims to show utility of biomedical shirt-based (Nuubo) electrocardiography monitoring of patients with CVD in different clinical situations


1) Perez de Isla L et al. New generation dynamic, wireless and remote cardiac monitorization platform: a feasibility study. Int J Cardiol. 2011 Nov;153(1) 83-85. doi:10.1016/j.ijcard.2011.08.074. PMID: 21925751.

2) Leopoldo Pérez de Isla et al. Wearable wireless remote monitoring system: An alternative for prolonged electrocardiographic monitoring, In International Journal of Cardiology, Volume 172, Issue 1, 2014, Pages e43-e44, ISSN 0167-5273, Ver enlace
3) Balsam, Paweł, et al. "Study design and rationale for biomedical shirt-based electrocardiography monitoring in relevant clinical situations: ECG-shirt study." Cardiology Journal (2017).

Estratificación de riesgo de arritmias

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
Diagnostic Yield of Nuubo in Patients with a 24h Negative Holter Study and Persistent Symptoms
Diagnostic yield of long-term ECG monitoring with Nuubo in the detection of arrhythmias in ambulatory patients with negative 24h Holter and persistent symptoms Finished; Pending publication
- Diagnostic yield of the holter was 0% and increased to more than 25% with Nuubo
- Data suggests that 7 day monitoring could be a better strategy as a first line diagnosis test instead of 24h holter monitoring in symptomatic patients


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)

Detección de FA trás Ictus de origen desconocido

Study Overview
Impact / Conclusion
Wearable Holter for AF detection in high risk patients after cryptogenic Stroke (CRYPTOFA) 1
Detection of AF after cryptogenic stroke with a new Textile Wearable Holter (TWH) device with early (24h-72h) and prolonged (4 weeks) of ECG monitoring
- Monitoring time was 30 days with AF detected in 21.9% of patients.
- Results superior to reference publications in the field, EMBRACE (14.8%) and CRYSTAL-AF (4.3%)
- Patient comfort was 4.2 / 5 and more than 90% of patients completed the expected wear time
- Nuubo ease of use permit to start patients monitoring immediately after stroke and also when to monitor the patient remotely at home, increasing considerably AF detection
Evaluation of the Atrial Fibrillation incidence in Subjects with Recent Cryptogenic Stroke (VAL.IN.F.A) Study a consecutive series of patients admitted to the Stroke Center for a cryptogenic stroke using NUUBO for a period of at least one month (30 days) Finished; Pending analysis
To prove long-term aECG diagnostic yield using nuubo up to 30 days
Identification and discrimination of AF in patients with Cryptogenic Stroke in Stockholm (CRYPTOHOLM)
Assess the identification and discrimination of AF with the use of Nuubo used on patients with Cryptogenic Stroke for 30 days Finished; Pending analysis
To prove long-term aECG diagnostic yield using nuubo for 30 days
AF Detection with Long Term Holter in Patients with Acute Cryptogenic Ischemic Stroke (DEFAPIC)
Study the prevalence of hidden AF using non-invasive long-term Holter monitoring for 21 days in patients with cryptogenic stroke Finished; Pending analysis
- To prove long-term aECG diagnostic yield using nuubo for 21 days
- To analyze the recurrence of cerebrovascular episodes in the next month and at 3 months to determine the change of treatment derived of the AF findings. Nuubo lack of adhesives permits flexible monitoring strategies to monitor the same patient in different recording times


1)Jorge Pagola et al. "Yield of atrial fibrillation detection with Textile Wearable Holter from the acute phase of stroke: Pilot study of Crypto-AF registry", In International Journal of Cardiology, 2017, ISSN 0167-5273.


Diagnostic Yield for Cryptogenic Stroke Patients Benchmarking
Clinical Evidence in Medium and Long-term aECG Monitoring after Cryptogenic Stroke

Clasificación y Diagnóstico de FA

Study Overview
Impact / Conclusion
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
Early prediction of AF in patients at risk Identify biomarkers as surrogates of underlying latent atrial dysfunction that predict development of AF on population at high risk in order to allow for early detection of the arrhythmia Ongoing
- AF screening in medium-high risk population may help to prevent stroke and other AF comorbolidities
- Many biomarkers are being identified but only long-term ECG monitoring may diagnose an arrhythmia today
Sequential clinic-electro- Biological screening of AF among high risk individuals (AFRICAT) 2 Development and validation of a multimodal sequential screening program for AF at primary care Ongoing
Determine the most suitable pulse device for AF detection to be used in primary care centers
Detection of Hidden AF at Primary Care in Risk population Study the prevalence of non- diagnosed AF in the population at risk Ongoing
- Establish the efficiency and applicability of a wearable ECG as a screening tool at the risk population in the primary care setting
- Prevalence is estimated to be higher than current estimation leading for a new and large segment for aECG prolonged monitoring


1) Fraile Sanz, A., et al. "P1584 A HCN4 previously undescribed variant in a large kindred with familial atrial fibrillation." EP Europace 19.suppl_3 (2017): iii335-iii336. 2) NCT03188484 - Atrial Fibrillation Research In CATalonia (AFRICAT) - Ver enlace

FA tras Ablación de Venas pulmonares

Study Overview
Impact / Conclusion
Post-AF Ablation monitoring to assess efficacy of ablation (plusONE) 1 Prospective registry of post AF ablation procedures using 5 different ablation techniques. 30 days of monitoring at 3, 6 and 12 months
- Recurrence detected in 35% of patients
- Results show that post-monitorization of AF ablation could be important to know the real outcome of the ablation and possible repeat of the procedure
- Nuubo’s lack of adhesives allows for flexibility in monitoring strategies. Patients may be monitored with the same Nuubo device 30 days at 4 months post ablation and another 30 days at 12 months post ablation
Post-AF Ablation monitoring to assess Redo procedure with Rotor ablation (REDO-FIRM) 2 Assess the safety and effectiveness of FIRM-guided (Topera) procedures in conventional "redo" RF ablation procedures for the treatment of AF
- Study sponsored by Abbott
- Results could show that Rotor ablation is more accurate than RF ablation
- Post AF ablation monitoring could be important to know the real outcome of the ablation, showing that Nuubo could be bundled/included in the ablation procedure

Síncope

Study Overview
Impact / Conclusion
Diagnostic efficacy of Nuubo prior to the use of a ILR (Syncoband) Assess the percentage of pathology detected using the Nuubo in patients with syncope or an occasional pathology of unknown cause Finished; Pending publication
- Nuubo can be useful and cost effective as a bridge to diagnosis test before ILR implantation
- Preliminary results show a diagnostic yield of ~20% in 60 days


1) NCT02789358 - A Time-to- effect Based Dosing Strategy in Cryoballoon Ablation of Patients With Paroxysmal Atrial Fibrillation (plusONE) - Ver enlace
2) NCT02799043 - Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With Focal Impulse and Rotor Modulation Guided Procedures (REDO-FIRM) Ver enlace

Pediatría

Study Overview
Impact / Conclusion
Pilot test with Nuubo in pediatric patients 1 Prospective study of 10 consecutive patients wearing Nuubo to assess the feasibility in pediatric population
- Patient compliance is good because Nuubo is more comfortable for patients than the traditional wired electrode holter system
- Patient families report high satisfaction with Nuubo
- Nuubo is a valid and useful tool in pediatric patients with symptoms of arrhythmias
Initial Experience with Nuubo in pediatric patients 2 Analyze the initial experience in this center using Nuubo
- Nuubo monitoring could be a useful tool in the study of arrhythmias
Detection and management of dysrhythmia in pediatric population 3 Assess the feasibility, accuracy and comfort of Nuubo in the pediatric population
- Nuubo is a helpful diagnostic tool for patients with suspected rhythm disorders covering a wide age and size range
- Nuubo shows impressive signal quality and precise detection of arrhythmias
- This study validates Nuubo as a helpful tool in the diagnosis of arrythmias in pediatric population
Arrhythmia Burden with Long- term ECG monitoring in pediatric Hypertrophic Cardiomyopathy (SABLE-HCM) Determine the feasibility of Nuubo in children with HCM and determine prevalence of non-sustained ventricular arrhythmias in children and adolescents with HCM Finished; Has not been published
- Results could show similar results to adult population (five times more detection than 24h holter)
- Could change the guidelines and diagnostic flow for these patients, eliminating the need of 24h holter and using Nuubo as a first line diagnostic test


1) Poster at XI SECPCC (Spanish Society of Pediatric Cardiology and Congenital Diseases)

Congress, 2016. 2) Poster at XI SECPCC (Spanish Society of Pediatric Cardiology and Congenital Diseases) Congress, 2016.

3) Fernandez, S. S., et al. "Filling the Gap in the Detection and Management of Dysrhythmia: The Life Vest." The Thoracic and Cardiovascular Surgeon 65.S 02 (2017): ePP78.

Arritmias generadas por deporte

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
QT Analysis in Top Level Athletes with Nuubo Study differences in the QT intervals during different levels of activity with Nuubo in professional athletes Ongoing (to be finished Q4 2017); 500 athletes
- Excellent ECG signal during intense sport
- Allows the athletes to be monitored during their sport, not a treadmill test
- Very high compliance for athletes
- Aims to establish new standards of QT interval by sex and sport performed
Nuubo screening in healthy non professional runners in a 10 km race Evaluate ECG and cardiac condition in asymptomatic patients during their participation in a 10 km race Internal technology validation study Finished; Has not been published
- Excellent signal quality and compliance
- Some form of dysrrhythmia found in 7.1% of patients
- Nuubo monitoring could be a useful tool in studying athletes during non-professional 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 – Rehabilitación Cardiaca

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 than 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
Nuubo technology (Wearcare) validation in ambulatory cardiac rehabilitation program 2 Evaluate the feasibility of Nuubo system during a an ambulatory cardiac rehabilitation program Internal technology validation study
- Nuubo proved to be effective and achieved a high patient adherence to the program
- Diagnostic quality of the aECG signal averaged above 91% during monitored time


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
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