HealthyECGNCT05591157
Evaluation of CSF-3 in Performing ECG
A study testing CSF-3 watch, designed to monitor a user's heart rate based on ECG (electrocardiogram) and PPG (Photoplethysmograph) readings in people with Healthy and ECG, run by CardiacSense Ltd. at 1 site in United States.
Trial summary
CSF-3 is a wrist-worn medical device similar to a watch. It is designed to monitor a user's heart rate based on ECG (electrocardiogram) and PPG (Photoplethysmograph) readings, using off-the-shelf ECG and unique PPG chipsets with proprietary algorithms. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- What is being tested?
- CSF-3 watch, designed to monitor a user's heart rate based on ECG (electrocardiogram) and PPG (Photoplethysmograph) readings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2022to 1 Feb 2023
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 21 years old
- Able and willing to understand and sign the informed consent and follow instructions
- Screening ECG results of Sinus Rhythm
- Wrist size 14 cm (5.5"), Max 20 cm (7.8")
Who cannot join
- Subjects who are currently enrolled in other clinical investigation
- Subjects diagnosed with a cardiac disorder or any cardiac symptoms
- Subjects with SNR < 100
- Subjects with ECG quality range > 1 and < 30
- Individuals with electrical pacing by a pacemaker
- Subjects who are pregnant or breastfeeding
Show all 11Show fewer
- Subjects with callous on the index finger or thumb (at fingerprint area)
- Subjects with active wound, prior soft tissue injury or skin conditions at the measurement location Sensitivity to the device material or ECG patches
- Subjects with tremors or otherwise unable to remain still for 15 minutes
- Subjects without two hands and sufficient fingers to complete the study
- Subjects unable to participate based upon investigator discretion
Trial locations and contacts
1 site in 1 country.
United States1 site
Fairview Health Services
Minneapolis, Minnesota, 55102
About this study
Official title: A Prospective Study for Evaluating the Safety and Performance of CSF-3 ECG Lead-I, HR and PR When Compared to ECG Holter
CSF-3 is a wrist-worn medical device similar to a watch. It is designed to monitor a user's heart rate based on ECG (electrocardiogram) and PPG (Photoplethysmograph) readings, using off-the-shelf ECG and unique PPG chipsets with proprietary algorithms. ECG and PPG are the two primary technologies for measuring heart rate. ECG measures the bio-potential generated by electrical signals that control the expansion and contraction of heart chambers, while PPG uses light-based technology to sense the rate of blood flow as controlled by the heart's pumping action.
Read the detailed description
The proposed clinical study is a prospective, open, single-center study to evaluate the performance and accuracy of the ECG and heart rate calculation of the CSF-3 investigational Device.
Subjects will be screened by the Principal Investigator. Subjects who meet the study's enrolment criteria will be recruited and fitted with an FDA cleared ECG Holter, and with the investigational Device (CSF-3).
At least 40 eligible subjects will be enrolled in a single center. Data collected from the subjects during the study will be included in the overall performance analysis of the ECG output. Subjects will perform an ECG and CSF-3 Device simultaneously Subjects will remain connected to both the ECG Holter and the CSF-3 Device at the study site for at least 7 minutes duration. The ECG and Holter will be stopped simultaneously. Both recordings data (ECG and CSF-3) will be uploaded and then synchronized offline using a dedicated and validated tool.
- Being tested
- CSF-3 watch, designed to monitor a user's heart rate based on ECG (electrocardiogram) and PPG (Photoplethysmograph) readings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSF-3 watch, designed to monitor a user's heart rate based on ECG (electrocardiogram) and PPG (Photoplethysmograph) readingsDevice
Also called FDA cleared ECG Holter
The subjects will be connected to an ECG Holter, and an investigational Device will be placed simultaneously on the subject's wrist. All subjects in this phase will be asked to participate in a single continuous data recording measurement for seven (7) minutes
| Study group | Role | What they receive |
|---|---|---|
| CSF-3 and ECG Holter | Experimental | At least 40 healthy subjects with no relevant or cardiac medical history and negative cardiac symptoms. Subjects will perform an ECG spot-check measurement using the CSF-3 Device while simultaneously being connected to an ECG Holter. Recording duration for both ECG Holter and CSF-3 device will be at least 7 minutes. Receives: Device: CSF-3 watch, designed to monitor a user's heart rate based on ECG (electrocardiogram) and PPG (Photoplethysmograph) readings |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSF-3 efficacy in ECG detection
Performance endpoint is defined as the ability of CSF-3 to detect beat-by beat Heart Rate in ECG signal with a sensitivity of no less than 96%, considering a false detection rate of not higher than 2%, and PPV of 80%.
Measured: 6 months
Secondary outcomes (1)
CSF-3 HR calculation
Performance endpoint is defined as the calculation of average Heart Rate with ARMS error<3BPM
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start16 Nov 2022
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- clinical study is a prospective, open, single-center study to evaluate the performance and accuracy of the ECG and heart rate calculation of the CSF-3 investigational Device.
- Masking
- None (open label)
- Enrolment
- 47 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
- NCT05591157
- Sponsor's protocol ID
- CSF-3 ECG
- Acronym
- ECG
- Status last verified
- Feb 2023
- First submitted
- 19 Oct 2022
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study for Evaluating the Safety and Performance of CSF-3 ECG Lead-I, HR and PR When Compared to ECG Holter
- ClinicalTrials.gov ID
- NCT05591157
- Acronym / sponsor ID
- ECG / CSF-3 ECG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- CardiacSense Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Nov 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 24 Oct 2022 (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.
CSF-3 is a wrist-worn medical device similar to a watch. It is designed to monitor a user's heart rate based on ECG (electrocardiogram) and PPG (Photoplethysmograph) readings, using off-the-shelf ECG and unique PPG chipsets with proprietary algorithms. ECG and PPG are the two primary technologies for measuring heart rate. ECG measures the bio-potential generated by electrical signals that control the expansion and contraction of heart chambers, while PPG uses light-based technology to sense the rate of blood flow as controlled by the heart's pumping action.
Detailed description
The proposed clinical study is a prospective, open, single-center study to evaluate the performance and accuracy of the ECG and heart rate calculation of the CSF-3 investigational Device.
Subjects will be screened by the Principal Investigator. Subjects who meet the study's enrolment criteria will be recruited and fitted with an FDA cleared ECG Holter, and with the investigational Device (CSF-3).
At least 40 eligible subjects will be enrolled in a single center. Data collected from the subjects during the study will be included in the overall performance analysis of the ECG output. Subjects will perform an ECG and CSF-3 Device simultaneously Subjects will remain connected to both the ECG Holter and the CSF-3 Device at the study site for at least 7 minutes duration. The ECG and Holter will be stopped simultaneously. Both recordings data (ECG and CSF-3) will be uploaded and then synchronized offline using a dedicated and validated tool.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- clinical study is a prospective, open, single-center study to evaluate the performance and accuracy of the ECG and heart rate calculation of the CSF-3 investigational Device.
| Arm | Type | Receives |
|---|---|---|
| CSF-3 and ECG Holter | Experimental | Device: CSF-3 watch, designed to monitor a user's heart rate based on ECG (electrocardiogram) and PPG (Photoplethysmograph) readingsAt least 40 healthy subjects with no relevant or cardiac medical history and negative cardiac symptoms. Subjects will perform an ECG spot-check measurement using the CSF-3 Device while simultaneously being connected to an ECG Holter. Recording duration for both ECG Holter and CSF-3 device will be at least 7 minutes. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 21 years old
- Able and willing to understand and sign the informed consent and follow instructions
- Screening ECG results of Sinus Rhythm
- Wrist size 14 cm (5.5"), Max 20 cm (7.8")
Key exclusion criteria (11 listed)
- Subjects who are currently enrolled in other clinical investigation
- Subjects diagnosed with a cardiac disorder or any cardiac symptoms
- Subjects with SNR < 100
- Subjects with ECG quality range > 1 and < 30
- Individuals with electrical pacing by a pacemaker
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 |
|---|---|---|
| CSF-3 watch, designed to monitor a user's heart rate based on ECG (electrocardiogram) and PPG (Photoplethysmograph) readingsAlso: FDA cleared ECG HolterThe subjects will be connected to an ECG Holter, and an investigational Device will be placed simultaneously on the subject's wrist. All subjects in this phase will be asked to participate in a single continuous data recording measurement for seven (7) minutes | Device | CSF-3 and ECG Holter |
Primary outcome
CSF-3 efficacy in ECG detection
Time frame: 6 months
Performance endpoint is defined as the ability of CSF-3 to detect beat-by beat Heart Rate in ECG signal with a sensitivity of no less than 96%, considering a false detection rate of not higher than 2%, and PPV of 80%.
1 secondary outcome
CSF-3 HR calculation
Time frame: 6 months
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 10 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Healthy
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils
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 CSF-3 watch, designed to monitor a user's heart rate based on ECG (electrocardiogram) and PPG (Photoplethysmograph) readings in people with Healthy and ECG, run by CardiacSense Ltd. at 1 site in United States.
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 11 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 10 Feb 2023. 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 United States. 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?
CSF-3 efficacy in ECG detection (time frame: 6 months). 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 10 Feb 2023.