Atrial FibrillationNCT04353453
Study to Evaluate the Performance of CardiacSense PPG Sensor
A study testing Study Procedure for Participants That Were Not in the Driving Group and Study Procedure for Participants That Were Included in the Driving Group in people with Atrial Fibrillation, run by CardiacSense Ltd. at 1 site in Israel.
Trial summary
study to evaluate the performance of the CardiacSense1's embedded PPG under different environmental and physical conditions Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Study Procedure for Participants That Were Not in the Driving Group and Study Procedure for Participants That Were Included in the Driving Group
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteIsrael
- Study dates
- 19 Feb 2018to 18 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age of eighteen to eighty-five (18-85) years
- Ability and willing to sign informed consent form
- For subjects in groups other than Heart Arrhythmias- Self-declared not to be diagnosed with any arrhythmia
- Compliance with hair, age, BMI skin and heart arrhythmia variables as defined above
Who cannot join
- Concurrent enrollment in another device or drug trial that has not completed the primary endpoint or clinically interferes with the current study endpoints.
- Subject with low perfusion indicated by the watch
- Pregnant or breastfeeding woman (women of child-bearing potential must have a negative pregnancy test within screening period).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Single-Center, Controlled Study to Evaluate the Performance of CardiacSense PPG Sensor in the CardiacSense1 Device
study to evaluate the performance of the CardiacSense1's embedded PPG under different environmental and physical conditions
Read the detailed description
The clinical study is a Prospective, Open, Single-Center, and Controlled Study to Evaluate the Performance of a PPG sensor in the CardiacSense1 device.
The CardiacSense1 is a wrist worn device designed to detect atrial fibrillation (AF). The AF detection of the device is based on a portable photoplethysmograph (PPG) sensor that is designed for continuous heart rate monitoring. The photoplethysmograph is a noninvasive circulatory signal related to the pulsatile volume of blood in the tissue.
Twenty (20) subjects (female and male) that do not suffer from atrial defibrillation and additional four (4) patients who are diagnosed as suffering from atrial fibrillation will be enrolled to the study.
Comparison of CardiacSense1 PPG individual peak detection to the corresponding recorded activity of an FDA-cleared ECG Holter, on a beat-by-beat basis will be performed on the following conditions:
All subjects will be exposed to 45 minutes of indoor standard office fluorescent light and 45 minutes to outdoor sunlight during mid-day. In addition, Subjects will be asked to walk for 1 minute once every 10 minutes and will be exposed to an indoor environment of 22±3 - 28±3 degree Celsius for 45 minutes and outdoor temperature of at least 15 degree Celsius, on the other 45 minutes.
4 Subjects will be tested in the following conditions: driving a car for 30 minutes; High wrist hair density subjects; Two subjects 65 y/o or older, two subjects 30 y/o or younger; Two subjects with BMI below 18.5 (underweight) and two subjects with BMI over 30 (Obesity); Two subjects with skin type 6 (Fitzpatrick) and two subjects with skin type 5; Four subjects with diagnosed persistent atrial fibrillation.
- Conditions
- Atrial Fibrillation
- Being tested
- Study Procedure for Participants That Were Not in the Driving Group, Study Procedure for Participants That Were Included in the Driving Group
- Keywords
- Cardiology
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study Procedure for Participants That Were Not in the Driving GroupDevice
Subjects were fitted with One lead Holter monitor and the CardiacSense1 watch simultaneously and were tested in the following condition:
- Sitting down for 10 minutes, walking for one minute and repeat this sequence twice at Indoor 28 ±3 degree Celsius.
- Sitting down for 10 minutes, walking for one minute and repeat this sequence twice at Indoor 22 ±3 degree Celsius.
- Sitting down for 10 minutes,outdoor walking for one minute and repeat this sequence four times At the end the devices were removed from the subject by the medical staff.The recorded data was downloaded for analysis by the Sponsor
Study Procedure for Participants That Were Included in the Driving GroupDevice
Subjects were fitted with One lead Holter monitor and the CardiacSense1 watch simultaneously and were tested in the following condition:
- Sitting down for 10 minutes, walking for one minute and repeat this sequence twice at Indoor 28 ±3 degree Celsius.
- Sitting down for 10 minutes, walking for one minute and repeat this sequence twice at Indoor 22 ±3 degree Celsius.
- Going from the indoor facility to the car and driving for 30 minutes at least. Subject drove the car in city streets under light traffic conditions. At the end the devices were removed from the subject by the medical staff.The recorded data was downloaded for analysis by the Sponsor
What is being measured
The primary outcome is the main question the study is designed to answer.
PPG individual peak detection
Comparison of CardiacSense1 PPG individual peak detection to the corresponding recorded activity of an FDA-cleared ECG Holter, on a beat-by-beat basis.
Measured: 90 Minutes
PPG and Holter ECG signals correlation
Evaluation of the correlation between PPG signals and Holter ECG signals with respect to R-R signal intervals.
Measured: 90 Minutes
Secondary outcomes (2)
signal intensity under different conditions
Examination of PPG signal optic parameters (LED current, LED intensity) and signal intensity under different conditions.
Measured: 90 minutes
Adverse events
Rate of Adverse events related or unrelated to the study device.
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start19 Feb 2018
- Primary completion18 Mar 2019
- Study completion18 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- CardiacSense Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353453
- Sponsor's protocol ID
- CL00201
- Status last verified
- Apr 2020
- First submitted
- 16 Apr 2020
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD is not available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center, Controlled Study to Evaluate the Performance of CardiacSense PPG Sensor in the CardiacSense1 Device
- ClinicalTrials.gov ID
- NCT04353453
- Acronym / sponsor ID
- CL00201
- Conditions
- Atrial Fibrillation
- Keywords
- Cardiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- CardiacSense Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 18 Mar 2019 (actual)
- Study completion
- 18 Mar 2019 (actual)
- First posted
- 20 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
study to evaluate the performance of the CardiacSense1's embedded PPG under different environmental and physical conditions
Detailed description
The clinical study is a Prospective, Open, Single-Center, and Controlled Study to Evaluate the Performance of a PPG sensor in the CardiacSense1 device.
The CardiacSense1 is a wrist worn device designed to detect atrial fibrillation (AF). The AF detection of the device is based on a portable photoplethysmograph (PPG) sensor that is designed for continuous heart rate monitoring. The photoplethysmograph is a noninvasive circulatory signal related to the pulsatile volume of blood in the tissue.
Twenty (20) subjects (female and male) that do not suffer from atrial defibrillation and additional four (4) patients who are diagnosed as suffering from atrial fibrillation will be enrolled to the study.
Comparison of CardiacSense1 PPG individual peak detection to the corresponding recorded activity of an FDA-cleared ECG Holter, on a beat-by-beat basis will be performed on the following conditions:
All subjects will be exposed to 45 minutes of indoor standard office fluorescent light and 45 minutes to outdoor sunlight during mid-day. In addition, Subjects will be asked to walk for 1 minute once every 10 minutes and will be exposed to an indoor environment of 22±3 - 28±3 degree Celsius for 45 minutes and outdoor temperature of at least 15 degree Celsius, on the other 45 minutes.
4 Subjects will be tested in the following conditions: driving a car for 30 minutes; High wrist hair density subjects; Two subjects 65 y/o or older, two subjects 30 y/o or younger; Two subjects with BMI below 18.5 (underweight) and two subjects with BMI over 30 (Obesity); Two subjects with skin type 6 (Fitzpatrick) and two subjects with skin type 5; Four subjects with diagnosed persistent atrial fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age of eighteen to eighty-five (18-85) years
- Ability and willing to sign informed consent form
- For subjects in groups other than Heart Arrhythmias- Self-declared not to be diagnosed with any arrhythmia
- Compliance with hair, age, BMI skin and heart arrhythmia variables as defined above
Key exclusion criteria (3 listed)
- Concurrent enrollment in another device or drug trial that has not completed the primary endpoint or clinically interferes with the current study endpoints.
- Subject with low perfusion indicated by the watch
- Pregnant or breastfeeding woman (women of child-bearing potential must have a negative pregnancy test within screening period).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study Procedure for Participants That Were Not in the Driving GroupSubjects were fitted with One lead Holter monitor and the CardiacSense1 watch simultaneously and were tested in the following condition: 1. Sitting down for 10 minutes, walking for one minute and repeat this sequence twice at Indoor 28 ±3 degree Celsius. 2. Sitting down for 10 minutes, walking for one minute and repeat this sequence twice at Indoor 22 ±3 degree Celsius. 3. Sitting down for 10 minutes,outdoor walking for one minute and repeat this sequence four times At the end the devices were removed from the subject by the medical staff.The recorded data was downloaded for analysis by the Sponsor | Device | – |
| Study Procedure for Participants That Were Included in the Driving GroupSubjects were fitted with One lead Holter monitor and the CardiacSense1 watch simultaneously and were tested in the following condition: 1. Sitting down for 10 minutes, walking for one minute and repeat this sequence twice at Indoor 28 ±3 degree Celsius. 2. Sitting down for 10 minutes, walking for one minute and repeat this sequence twice at Indoor 22 ±3 degree Celsius. 3. Going from the indoor facility to the car and driving for 30 minutes at least. Subject drove the car in city streets under light traffic conditions. At the end the devices were removed from the subject by the medical staff.The recorded data was downloaded for analysis by the Sponsor | Device | – |
Primary outcome
PPG individual peak detection
Time frame: 90 Minutes
Comparison of CardiacSense1 PPG individual peak detection to the corresponding recorded activity of an FDA-cleared ECG Holter, on a beat-by-beat basis.
PPG and Holter ECG signals correlation
Time frame: 90 Minutes
Evaluation of the correlation between PPG signals and Holter ECG signals with respect to R-R signal intervals.
2 secondary outcomes
signal intensity under different conditions
Time frame: 90 minutes
Adverse events
Time frame: 90 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Individual participant dataSharing planned: No. IPD is not available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Procedure for Participants That Were Not in the Driving Group and Study Procedure for Participants That Were Included in the Driving Group in people with Atrial Fibrillation, run by CardiacSense Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PPG individual peak detection (time frame: 90 Minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020.