Clinical Trials

Title 

Pilot study MMT- Continuous PPG measurement  in presumably healthy people/ non clinical environment.

Topic 

Data collection of continuous PPG signals recorded by MMT wearables and evaluation of the performance and efficacy of the IT infrastructure between MMT and Perventicus by automatically sending  the continuous PPG measurements to Preventicus Server.  Adaptation of the Preventicus algorithm  to MMT PPG data in order that no signal characteristics, artefacts or movements lead to abnormal results. 

Number of Participants 

40 presumably healthy people 

Inclusion / Exclusion criteria

Inclusion criteria:

• presumably healthy people
• People ≥ 18 years old
• non clinical environment

Exclusion criteria:

• Smartwatch cannot be worn due to comprehensible reasons (allergic reactions, wounds, amputations, other)

Study Design 

Presumably healthy people wear a PPG wearables (provided by MMT) and measure continuous PPG over 24-48h. The PPG signal will send automatically to MMT server and further to Preventicus server. The continuous PPG measurements will be analyzed by Preventicus algorithm (heart rate and heart rhythm)

Target points 

Primary outcome:

• Efficacy and Completeness of data collection and data transfer of continuous PPG signals  between MMT and Preventicus: 
• Amount of PPG data in minutes, collected and transferred completely wearing the wearable 24-48h
• Rate of usable PPG data
• Rate of presumably false positive screening results (AF)

Measurement procedures 

Duration of the measurement: 48h

Automatic data transfer 

Automatic analysis by preventicus algorithm 

Evaluation and verification by Telecare

No automatic transfer of results back to MMT wearable: 48h

Study Centre Preventicus Jena (DE)

Start time, Duration September 2020, 2 months

Title 

Validation of Photoplethysmography Measured Heart Rate and RR-intervals with the Corsano CardioWatch 287 Module Compared with ECG 

Topic 

To study the feasibility, efficacy and performance of the Corsano CardioWatch 287 module  with a photoplethysmographic sensor for measuring heart rate and RR-intervals

Number of Participants 

100 presumably healthy people

Inclusion / Exclusion criteria

Inclusion criteria:

• presumably healthy people
• People ≥ 18 years old
• non clinical environment

Exclusion criteria:

• Bracelet cannot be worn due to comprehensible reasons (allergic reactions, wounds, amputations, other)

Study Design 

Patients fulfilling the inclusion criteria will receive a wearable device (Corsano CardioWatch 287 provided by MMT) and a smartphone with the MMT-App. The smartwatch and the app on the smartphone are coupled. Continuous monitoring of heart rate and –rhythm will be conducted using photoplethysmography (PPG). Simultaneously, a 5 min resting ECG recording will be conducted. Data obtained with the Corsano CardioWatch 287 will be saved on the smartphone and will be downloaded by the physician at the end of the monitoring procedure. Data will then be analysed by trained analysts and supervising physicians at Cardiologie Centra Nederland. The PPG data from the Corsano CardioWatch 287 will be compared to a 5 minute, 12-lead resting ECG recording on the measurement of heart rate and RR-intervals.

Target Points

Main study parameters/endpoints: Percentage of heart rate and RR-intervals of the PPG sensor matching the resting ECG recording

Measurement procedures 

Participants are requested to wear a smartwatch or bracelet for 5 minutes in addition to a resting ECG. Simultaneously, they will have the connected smartphone with them. 

Study Centre

Cardiologie Centra Nederland, Amsterdam UMC, Location AMC (NL)

Start time, Duration

September 2020, 4 months

Title 

Validation of Respiratory Rate with the Corsano CardioWatch 287 Compared with Polygraphy

Topic 

Evaluation of the performance and efficacy of the Corsano CardioWatch 287 in measuring respiratory rate at rest, as compared to golden standard and predicate device.

Number of Participants 

25 subjects (at least 30% of each gender)

Inclusion / Exclusion criteria

Inclusion criteria:
People ≥ 18 years old

Exclusion criteria:
Wearer of cardiac implanted electronic device (Pacemaker, ICD)
CardioWatch 287 cannot be worn due to comprehensible reasons (allergic reactions, wounds, amputations, other)
Unable or not willing to sign informed consent
Significant mental or cognitive impairment
Currently enrolled in another clinical investigation in which the intervention might compromise the safety of the subject’s participation in this study

Study Design 

The patients are selected from the patient population referred for an overnight Polygraphy exam for a suspicion of sleep-disordered breathing. Patients are scheduled for a Respiratory Rate measurement, independent of the proposed study. Patients that are scheduled for these examinations and meet the inclusion criteria (see below) are approached by their practitioner or specialized nurse supervised by the for participation in the trial.

Target Points

The main study endpoints are the Percentage of respiratory rates of matching the resting Polygraphy recording. Percentage of respiration rate at rest ±2 BPM (beats per minute) matching the polygraphy device and manual counting.

Measurement procedures 

Participants are requested to wear a smartwatch or bracelet in addition to a Polygraph. Simultaneously, they will have the connected smartphone with them. 

Study Centre

Haaglanden Clinics (NL)

Start time, Duration

November 2020, 6 months

Title 

Determine AF Burden with PPG Trial – Detection and Quantification of Episodes of Atrial Fibrillation Using a Wearable with Photoplethysmographic (PPG) Sensor

Topic 

Evaluation of the performance of the Preventicus algorithm in identifying AF episodes and determining the AF burden in patients with known paroxysmal AF

Number of Participants 

100 patients with known paroxysmal atrial fibrillation

Inclusion / Exclusion criteria

Inclusion criteria:

• Known paroxysmal atrial fibrillation
• Patient ≥ 18 years old
• Written informed consent as documented by signature from the patient

Exclusion criteria:

• Cardiac implanted electronic device (Pacemaker, ICD)
• Bracelet cannot be worn due to comprehensible reasons (allergic reactions, wounds, amputations, other)
• Unable or not willing to sign informed consent
• Significant mental or cognitive impairment
• Currently enrolled in another clinical investigation in which the intervention might compromise the safety of the subject’s participation in this study

Study Design 

In this trial patients with known paroxysmal AF wear a PPG wearable (provided by Corsano) and measure continuous PPG over 48h.The PPG data will be stored on a smartphone app connected to the wearable. Simultaneously the ecg signal will be recorded continuously by holter ecg. The PPG data has to be downloaded manually and sent to Preventicus. The Preventicus algorithm analyzes the PPG data to screen for AF episodes. Positive screening results will be verified by Telecare. The ecg data will be evaluated by two independent cardiologists blinded to each other and in agreement with the aim to identify AF episodes. The results of the PPG analysis by preventicus verified by Telecare and the results of the ecg evaluation by cardiologists will be compared. Preventicus will be also blinded to the ecg and the evaluations of the cardiologists.

Target points 

Primary outcome:

• Detected atrial fibrillation (in comparison to simultaneously recorded continuous Holter-ECG)

Secondary outcomes:

• Overall duration of the atrial fibrillation episodes and AF burden per 24h
• Asymptomatic episodes of atrial fibrillation

Measurement procedures 

Reference for assessing the performance and accuracy of the Preventicus Heartbeats algorithm are the diagnoses of the cardiologists based on the ECG data. 

Study Centre

Cardiology Centra Netherlands Location UMC

Start time, Duration

Q4 2020, 6 months

Title 

Determine AF Burden with PPG Trial – Detection and Quantification of Episodes of Atrial Fibrillation Using a Wearable with Photoplethysmographic (PPG) Sensor

Topic 

Evaluation of the performance of the Preventicus algorithm in identifying AF episodes and determining the AF burden in patients with known paroxysmal AF

Number of Participants 

100 patients with known paroxysmal atrial fibrillation

Inclusion / Exclusion criteria

Inclusion criteria:

• Known paroxysmal atrial fibrillation
• Patient ≥ 18 years old
• Written informed consent as documented by signature from the patient

Exclusion criteria:

• Cardiac implanted electronic device (Pacemaker, ICD)
• Smartwatch cannot be worn due to comprehensible reasons (allergic reactions, wounds, amputations, other)
• Unable or not willing to sign informed consent
• Significant mental or cognitive impairment
• Currently enrolled in another clinical investigation in which the intervention might compromise the safety of the subject’s participation in this study

Study Design 

In this trial patients with known paroxysmal AF wear a PPG wearable (provided by Corsano) and measure continuous PPG over 48h.The PPG data will be stored on a smartphone app connected to the wearable. Simultaneously the ecg signal will be recorded continuously by holter ecg. The PPG data has to be downloaded manually and sent to Preventicus. The Preventicus algorithm analyzes the PPG data to screen for AF episodes. Positive screening results will be verified by Telecare. The ecg data will be evaluated by two independent cardiologists blinded to each other and in agreement with the aim to identify AF episodes. The results of the PPG analysis by preventicus verified by Telecare and the results of the ecg evaluation by cardiologists will be compared. Preventicus will be also blinded to the ecg and the evaluations of the cardiologists.

Target points 

Primary outcome:

• Detected atrial fibrillation (in comparison to simultaneously recorded continuous Holter-ECG)

Secondary outcomes:

• Overall duration of the atrial fibrillation episodes and AF burden per 24h
• Asymptomatic episodes of atrial fibrillation

Measurement procedures 

Reference for assessing the performance and accuracy of the Preventicus Heartbeats algorithm are the diagnoses of the cardiologists based on the ECG data. 

Study Centre

Universitätsspital Basel (CH)

Start time, Duration

Q4 2020, 6 months

Title 

Accuracy of CardioWatch 287-2 with profound hypoxia (CIV-21-12-038447)

Topic 

The present study is looking for calibration and accuracy of SpO2, Pulse Rate and Respiration Rate derived by a newly developed based wrist device (CardioWatch 287-2 or Test Device). These parameters will be computed from raw PPG data delivered by Test Device based on values of a benchmark comparator:

• A well-known benchmark SpO2 sensor of Nellcor (PM10N), including its calculated pulse rate: The Non-Invasive study (NI study) branch.
• Oxygen saturation in arterial blood samples measured by co-oximetry and Nellcor SpO2 will be used to define the accuracy of the test device: The Invasive study (IN study).
• Respiratory rate is provided by measuring end tidal CO2 peaks by a capnometry in both studies.

Individuals undergo progressive hypoxia (10 min / % oxygen decrease) to 10 % of ambient O2 in a normobaric hypoxia room resulting in a subject’s SpO2 or SaO2 range between 97 to 100% and 73%. Nellcor’s finger clip, the wrist CardioWatch 287-2 and a small plastic tube placed near the mouth are attached to the volunteers before and during hypoxia.

Number of Participants 

In the first NI study, 12 to 20 healthy volunteers are included, because some minor refinement of the software in the Test Device to improve PPG signals is allowed in the first volunteers. This NI study stops after completing 12 volunteers with the final software version of the Test Device.

In the second IN study, released after completion of the NI study, an arterial catheter is placed to 12 volunteers to obtain arterial oxygen saturation measured by co-oximetry at several time points during progressive hypoxia (25 blood samples/person). Thereafter the accuracy (Arms) of the test device’s SpO2 will be computed.

Per FDA guidance, at least 2, or 15% of the subjects will have dark skin. Equal numbers of men and women will be enrolled.

Inclusion / Exclusion criteria

Inclusion Criteria:

• The subject is male or female, aged ≥18 and <65.
• The subject is in good general health with no evidence of any medical problems.
• The subject has provided informed consent and is willing to comply with the study procedures.

Exclusion criteria:

• Heavy smokers or individuals exposed to high levels of carbon monoxide that result in elevated carboxyhemoglobin levels.
• Individuals subject to conditions that result in elevated levels of methemoglobin
• Individuals with hypoxia (SpO2 < 95 % at 21 % of oxygen)
• Severe claustrophobia
• Subject is known with altitude disease
• The subject is obese (BMI ≥ 31 kg/m2).
• The subject has a known history of moderate to severe heart disease, lung disease, kidney or liver disease.
• The subject is diagnosed with moderate to severe asthma.
• The subject is known with a hemoglobinopathy or history of anemia, e.g. sickle cell anemia, thalassemia, … who, in the opinion of the investigator, would make them unsuitable for study participation.
• The subject has any other serious systemic illness.
• Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators would interfere with the sensors working correctly.
• The subject has a history of fainting or vasovagal response.
• The subject has a history of sensitivity or allergy to local anesthetics or disinfectants.
• The subject has a diagnosis of Raynaud’s disease.
• The subject has unacceptable collateral circulation based on exam by the investigator.
• The subject is pregnant, lactating or trying to get pregnant.
• The subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with study procedures.
• The subject has any other condition, which in the opinion of the investigators would make the subject unsuitable for the study.
• The subject refuses to remove nail-vanish.

Study Design

CardioWatch 287-2 is attached to the wrist. Subjects are in a comfortable semi-recumbent position. Subjects then breathe air mixtures containing reduced amounts of oxygen to produce the desired level of hypoxemia. Stable, safe and controlled hypoxia is achieved breath-by breath by breath respiratory gas analysis and a computer program that permits the inspired gas mixture to be adjusted to achieve a level of lung alveolar gas that will achieve the desired degree of saturation. Typically, saturation levels involve one period with air breathing and then at one of 6 levels with reduced oxygen, e.g. 94%, 90%, 85%, 80%, 75% and 70% saturation. Each level of saturation is held for 30-60 seconds. The operator then changes the inspired oxygen concentration to attain the next desired stead-state level of hypoxia. A “run” consists of several stable steady-state hypoxia levels and together takes 10-15 minutes. Each run is terminated by a breath of 100% O2 followed by room air. 2 Reference oximeters are used, a Nellcor and a Masimo to determine the blood oxygen saturation levels of the subject. The precise target levels of saturation can be adjusted to suit the sponsor, but typical testing is done to satisfy ISO and FDA standards for testing, which is 70% to 100%.

Measurement procedures 

The number of subjects and the number of comparisons (paired pulse oximeter readings and arterial saturation values) is determined by current CE-MDR and FDA guidance requirements. This is a minimum of 200 data points and 10 subjects. In the course of this type of study, some subjects may drop out, some readings can be lost due to motion or other interference and occasionally some do not consent.

The following demographic data will be collected on the subjects:

• gender (male, female, other)
• age
• skin tone (Fitspatrick’s skin color scale)
• height (cm)
• weight (kg)
• wrist circumference (cm)
• dominant hand (left or right)

Study Centre

CMC bvba
Europalaan 42b1
3600 Genk
BE 0449.103.169

Principle Investigator

Raf De Jongh, MD, PhD

Start time, Duration

April 2022, Two months

Title 

SmartAF – Monitoring of Atrial Fibrillation in Hospitalized Patients for Stroke Prevention 

Topic 

Evaluation of the diagnostic yield and confirmation rate of the Preventicus Heartbeats algorithm processing PPG data of a  Smartwatch in screening for AF in hospitalized patients.  

Number of Participants 

250 hospitalized patients  

Inclusion / Exclusion criteria

Inclusion criteria:

• Hospitalized patients on the internal medicine ward of USB
• CHA₂DS₂-VASc Score ≥ 2
• Written informed consent as documented by signature from the patient

Exclusion criteria:

• Current or prior diagnosis of AF
• Chronic anticoagulation therapy for other reasons 
• Cardiac implanted electronic device (Pacemaker, ICD)
• Smartwatch cannot be worn due to comprehensible reasons (allergic reactions, wounds, amputations, other)
• Unable or not willing to sign informed consent
• Significant mental or cognitive impairment

Study Design 

In this trial the Corsano CardioWatch 287 smart watch, provided by MMT, will be used to conduct continuous heart rate and –rhythm monitoring in hospitalized patients with moderate to high risk for AF. The collected PPG data is automatically fed into the hospital’s IT infrastructure and sent anonymously to Preventicus for analysis.  If an atrial arrhythmia is detected and verified by Telecare, patients receive a 14d-holter ECG for confirmation. 

Target points 

Primary outcome:

• Detected AF episodes

Secondary outcomes:

• AF screening durations
• Health economic simulation: costs per identified AF case after AF screening and after AF confirmation

Measurement procedures 

Reference to evaluate the performance and accuracy of the Preventicus Heartbeats algorithm are the diagnosis of the 14d Holter ecg, analysed by cardiologists. 

Study Centre

Universitätsspital Basel (CH) 

Start time, Duration

Q1 2021, 1.5 years

Title 

Case-finding Study to Detect and Quantify Episodes of Absolute Arrhythmia Using an Automated, Wearable Monitoring System (Smart in OAC)

Topic 

To demonstrate that patients with previously unknown atrial arrhythmias can be detected by a wearable in combination with Preventicus Heartbeats Core using a completely digital patient data capture system.

Number of Participants 

Patients to be screened: 2,000

Inclusion criteria
• Informed consent
• Mobile phone compatible with the PPG-wearable (see Appendix 3)
• Stable internet connection

Exclusion criteria
• Unwillingness to participate
• Inability to consent
• Known AF
• Known OAC treatment

Study Design 

In this study, the feasibility of evaluating the efficacy of a cloud based analytic service in combination with a Corsano CardioWatch 287  in detecting AA will be assessed and the number of cases found. The design aims to provide simple, low-threshold access to this screening technology targeting at-risk populations. This study will not cause any restrictions on the usual care of the study participants. Access to the screening will be provided close to home and free of charge. The app will also be used to validate and enhance the clinical information about the participants captured during the study. This information will be used to define and refine target groups with highest screening efficiency and, in the long-term, outcome benefits. The study will describe the prevalence of AA in an unselected population that can be reached by a low-threshold screening procedure. The study will also generate important information on the different possible screening environments in different countries (e.g. pharmacies, GP practices, etc). Structures of work-up and continuous patient management in screen-positive individuals will be described and may help to design screening pathways in the main trial. By verifying the wearable-diagnoses by ECG in all screen-positive and a random selection of screen-negative participants, the diagnostic accuracy of the wearable in combination of cloud based analytic service can be estimated. Cost effectiveness assessment will evaluate the cost of low-threshold remote screening per patient identified and help guide to target high risk groups with optimal screening yield in the future. The collected data will provide the sound basis for the design and conduct of a large outcome trial.

Target points 

The primary outcome will be
– Number of participants reached
– Number of participants with detected absolute (atrial) arrhythmia.

The secondary outcomes include:
– Rate of participants with newly detected absolute (atrial) arrhythmia
– Rate of participants with confirmed absolute (atrial) arrhythmia (sub-analysis: atrial fibrillation)

Measurement procedures 

Reference to evaluate the performance and accuracy of the Preventicus Heartbeats algorithm are the diagnosis of the 14d Holter ecg, analysed by cardiologists.

Study Centre

Germany: Hamburg
UK: Birmingham
Spain: Barcelona
Poland: Krakow (or Katowice)

Start time, Duration

Start: Q1 2021, Total study duration: 12 months
Duration per patient: 2 months

Title 

Atrial Fibrillation detection in OBESity using Ehealth

Topic 

Obesity is a global epidemic. Obesity is associated with an increased risk of atrial fibrillation (AF). AF is the most common sustained cardiac rhythm disorder in humans with potentially life threatening complications. Detection of subclinical AF in obesity patients would allow initiation of proper therapy and follow-up. However, to financially and logistically permit screening of subjects on AF, subjects with the highest risk of having AF should be identified. Currently, knowledge on the mechanisms through which obesity increases the risk of AF remains largely unclear and insufficient to develop such strategies. Franciscus Gasthuis & Vlietland is one of the largest bariatric surgery centers of The Netherlands, with multiple research projects focusing on the obesity patient. 

Number of Participants 

200 consecutive adult obesity patients undergoing bariatric surgery 

Inclusion / Exclusion criteria

Inclusion criteria

• BMI of ≥ 35 kg/m2
• scheduled for bariatric surgery
• age ≥ 50 years
• written informed consent

Exclusion criteria

• Known cardiac disease. Whether a patient has known cardiac disease will be determined by assessment of the available patient files and by asking the patient. 

Study Design 

The value of AF-screening will be studied in an investigator driven, cross sectional, observational cohort study of obesity patients (primary objective). Selected patients are obesity patients who are screened for bariatric surgery, aged 50 years and older, without a history of cardiac disease. Patients will undergo conventional and advanced echocardiography and laboratory tests as well to investigate signs of subclinical cardiac dysfunction that may be related to AF (secondary objective). Also, a prospective follow-up study of obesity patients undergoing bariatric surgery will be performed to gain insight in the pathophysiology of increased risk of AF in obesity (secondary objective). 

Target points 

The primary outcome will be 

• the proportion of obesity patients with AF as detected by 1 week heart rhythm registration with an AF-detection patch (before bariatric surgery)

The secondary outcomes include:

• Change in the proportion of obesity patients with any AF episode as detected by an AFdetection patch between study onset (1 week monitoring before surgery) and one year after surgery (1 week monitoring)
• Change in the proportion of obesity patients with any AF episode as detected by an ILR between study onset (3 months monitoring before surgery) and in the period of 9 to 12 months after surgery (3 months monitoring)

Study Centre

Franciscus Gasthuis & Gasthuis

Start time, Duration

Start: 1 september 2020, Total study duration: 18 months