Ongoing 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 

30 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 August / September 2020, 1 month

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, 1 month

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 MMT) 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

Q3 2020, 6 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 

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: 12 months