The device, the cardiac arrhythmia software, is intended to record, store and analyze the heart rate data collected by a PPG sensor to provide the user with notifications of events that indicate an irregular heart rhythm. The information is not…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sensitivity and specificity of a series of three measurements to detect atrial
fibrillation, premature heart rate and sinus rhythm.
a. Sensitivity and Specificity of Atrial Fibrillation Recognition
b. Sensitivity and Specificity of Premature Heart Rate Recognition
c. Sensitivity and specificity for identifying sinus rhythms.
Secondary outcome
Performance Endpoints
To measure the sensitivity and specificity of three consecutive measurements
and of a single measurement to detect atrial fibrillation, premature heartbeat
and sinus rhythm, single measurement results from arrhythmia analysis software
are compared with the interpretation results from the simultaneous ECG
recording.
Sensitivity and specificity of a single measurement to detect atrial
fibrillation, premature heartbeat and sinus rhythm.
a. Sensitivity and Specificity of Recognition of Atrial Fibrillation by Single
Measurement
b. Sensitivity and Specificity of Recognition of Premature Heart Rate by Single
Measurement
c. Sensitivity and specificity for identifying sinus rhythms in a single
measurement
Safety Endpoints
To determine safety, software failure rates and the incidence of adverse and
serious adverse events are recorded.
1. Software error rate (e.g. failures in getting a readout, delivering output,
etc.)
2. Incidence of Device or Procedure Adverse and Serious Adverse Events
Background summary
The intelligent portable arrhythmia detection device has advantages of
portability, real-time performance and low cost, and a user can take
measurements at any time, enabling early detection of arrhythmias. With this
information, a doctor can be approached in time for further diagnosis and/or
treatment.
In this open and controlled clinical study, the functioning of the Cardiac
Arrhythmia Analysis App is tested on patients with either a very light skin
tone or a very dark skin tone. The skin color is important, since the
measurement takes place on the basis of light by means of. photoplethysmograph,
(PPG sensor).
In this study adults, older than 18 years, can participate with or without
cardiac arrhythmias.
The subject will undergo at least 3 45-second ECG measurements, and a maximum
of 10 45-second measurements. The measurements with the EKG device are compared
with the results of the cardiac arrhythmia analysis app.
Study objective
The device, the cardiac arrhythmia software, is intended to record, store and
analyze the heart rate data collected by a PPG sensor to provide the user with
notifications of events that indicate an irregular heart rhythm. The
information is not intended for diagnosis and users should consult a physician
if they are concerned about the information provided.
Study design
An open, single center, controlled clinical trial of the effectiveness and
safety of the arrhythmia analysis app.
Study burden and risks
The patient is charged with wearing a smartwatch for a maximum of 1 hour. The
following risks may arise during this period:
1. A skin reaction after contact with the wearable, including skin allergy,
redness or itching of the electrode joint or any part of the wearable that
touches the skin.
2. This clinical trial is being initiated during the COVID-19 pandemic. The
same wearable device will be used on multiple patients. There is a risk of
virus transmission if an infectious patient wears the device and it is used on
the next patient without proper disinfection.
The following steps are taken to mitigate the above risks:
• No additional risk management measure for the risk of skin reactions due to
low impact and low probability.
• Smartwatches are wiped with a 70% ethanol solution between uses on different
patients to reduce the risk of cross-contamination.
Xincheng Road, Songshan Lake Campus 2
Guangdong 523808
CN
Xincheng Road, Songshan Lake Campus 2
Guangdong 523808
CN
Listed location countries
Age
Inclusion criteria
1. Age >18 of any sex; 2. Wrist circumference 140 mm - 210 mm; 3.
Fitzpatrick skin type 1, 2, 5, or 6 (pre-screening); 4. Melanin Index (MI)
<150 or >350 as measured on the inner arm; 5. One of the following
conditions, based on past 3 months' history or screening electrocardiogram: a.
Normal sinus rhythm; b. Persistent or permanent or onset atrial fibrillation;
c. Frequent (>5 beats per minute) premature beats or ongoing premature
beats; 6. Willing and able to provide voluntary, written informed consent.
Exclusion criteria
1. Patients using pacemakers or implantable cardioverter defibrillators (ICDs);
2. Patients with atrioventricular block or bundle branch block;
3. Patients with sinus tachycardia, significant sinus bradycardia, significant
sinus arrhythmia, sinus arrest or sick sinus syndrome;
4. Interpositional premature beats, dual-law premature beats, triple-law
premature beats, border premature beats or escape beat heart rhythm patients;
5. Patients with atrial tachycardia, atrial flutter, ventricular tachycardia,
ventricular flutter or ventricular fibrillation;
6. Patients with resting heart rate less than 50 times/minute or more than 110
times/minute;
7. Patients with tremor disease or chorea disease that are difficult to
cooperate in completing the examination while remaining still;
8. Bullous disease or generalized rash, and other patients not suitable for
surface electrode recording;
9. Patients with skin allergies to alcohol;
10. Patients with skin infectious diseases;
11. Patients with a history of mental illness or cognitive impairment;
12. Patients who have participated in other clinical trials that may affect
this trial within the past 30 days;
13. Concomitant medication that might interfere with study results;
14. Other situations where the researchers consider it inappropriate for a
patient to take part in the trial.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL78353.000.21 |