Atrium; FibrillationNCT03477734
Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation
A study testing CS1 & heart monitor in people with Atrium; Fibrillation, run by CardiacSense Ltd. at 2 sites in Israel.
Trial summary
A Prospective, Open, Multi-Center, Controlled Study to Evaluate the Safety, Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation. The clinical study is intended to establish the efficacy and safety of the CardiacSense1 wearable device intended to monitor and detect heart arrhythmia… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrium; Fibrillation
- What is being tested?
- CS1 & heart monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 2 sitesIsrael
- Study dates
- 20 Feb 2019to 9 Jun 2020
- 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 (18) year and above
- Diagnosed with atrial fibrilation (Permanent of persistent), or healthy participants able to and willing to sign the informed consent form For control group-no known cardiac problems
Who cannot join
- Subjects who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the subject's participation in this study.
- Subjects with low perfusion as indicated by the watch
- Women who are pregnant or breastfeeding
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Rambam Medical Center
Haifa
Sourasky Medical Center
Tel Aviv, 62431
About this study
Official title: A Prospective, Open, Multi-Center, Controlled Study to Evaluate the Safety, Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation
A Prospective, Open, Multi-Center, Controlled Study to Evaluate the Safety, Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation.
The clinical study is intended to establish the efficacy and safety of the CardiacSense1 wearable device intended to monitor and detect heart arrhythmia, specifically atrial fibrillation (A-Fib) based on a comparison to a control device, which is an off-the-shelf cleared Holter ECG device
Read the detailed description
The clinical study is intended to establish the efficacy and safety of the CardiacSense1 wearable device intended to monitor and detect heart arrhythmia, specifically atrial fibrillation (A-Fib). Study design as as follows:
100 subjects, 50 (at least 30% of each gender) with A-fib and 50 without (at least 30% of each gender).
All subjects will be measured during at least 24 hours. Primary endpoint - A-Fib detection Control: Holter device will be the reference
For PPG analysis, each one hour will be considered as an event:
If A-Fib is present for more than accumulated 5 minutes in that specific hour then it shall be considered an "A-Fib hour" If A-fib was present for less than accumulated 5 minutes then it shall be considered a "Non-A-Fib hour".
For ECG analysis, each measurement of between 1-3 minutes will be considered an event.
If A-Fib is present at that specific measurement, then it shall be considered an "A-Fib event" If A-fib was not present at that specific measurement, then it shall be considered a "Non-A-Fib hour".
Sensitivity (true positive) is defined as the percentage of Holter defined "A-fib hours"/"A-Fib event" found by PPG/ECG.
The asked sensitivity is 90%. Specificity (true negative) is defined as the percentage of Holter defined "Non-A-fib hours"/"A-Fib event" found by PPG/ECG. The required specificity is 90%.
- Conditions
- Atrium; Fibrillation
- Being tested
- CS1 & heart monitor
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS1 & heart monitorDevice
Daily activities while wearing the investigational device as well as the control device
| Study group | Role | What they receive |
|---|---|---|
| CS1 & heart monitor - AF patients | Experimental | Males and females diagnosed with atrial fibrillation will be fitted with the CardiacSense1 and Holter heart monitor for 24-48 hours while going about daily activities, results shall be compared and analysed Receives: Device: CS1 & heart monitor |
| CS1 & heart monitor -Healthy volunteers | Active comparator | Males and females not diagnosed with atrial fibrillation will be fitted with the CardiacSense1 and Holter heart monitor for 24-48 hours while going about daily activities, results shall be compared and analysed Receives: Device: CS1 & heart monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
CardicacSense1 atrial fibrillation detection rate
Comparison of the number of atrial fibrillation sessions detected by reference comparing to PPG and ECG sensors in CardiacSense device.
Measured: 24 to 48 hours
Safety of CardicacSense1
Incidence and severity of device related Adverse Events
Measured: 24 to 48 hours
Secondary outcomes (1)
Usability
Ease of use of the CardiacSense1 device based on user questionnaire
Measured: 24 to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start20 Feb 2019
- Primary completion25 Nov 2019
- Study completion9 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrium; 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Males and females, 50 of them diagnosed with atrial fibrillation (AF), and 50 healthy participants, at least 30% of each gender in each group.
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- CardiacSense Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ofer Havakuk, MD, PhD, Principal investigator, Department of Cardiology, Tel Aviv Medical Center and Sackler School of Medicine, Tel Aviv University, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477734
- Sponsor's protocol ID
- CL00001
- Status last verified
- Jul 2020
- First submitted
- 20 Feb 2018
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual data will be shared. Data analysis will include comparative overall data between investigational device and control device, as well as usability data
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open, Multi-Center, Controlled Study to Evaluate the Safety, Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03477734
- Acronym / sponsor ID
- CL00001
- Conditions
- Atrium; Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- CardiacSense Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 9 Jun 2020 (actual)
- First posted
- 26 Mar 2018 (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.
A Prospective, Open, Multi-Center, Controlled Study to Evaluate the Safety, Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation.
The clinical study is intended to establish the efficacy and safety of the CardiacSense1 wearable device intended to monitor and detect heart arrhythmia, specifically atrial fibrillation (A-Fib) based on a comparison to a control device, which is an off-the-shelf cleared Holter ECG device
Detailed description
The clinical study is intended to establish the efficacy and safety of the CardiacSense1 wearable device intended to monitor and detect heart arrhythmia, specifically atrial fibrillation (A-Fib). Study design as as follows:
100 subjects, 50 (at least 30% of each gender) with A-fib and 50 without (at least 30% of each gender).
All subjects will be measured during at least 24 hours. Primary endpoint - A-Fib detection Control: Holter device will be the reference
For PPG analysis, each one hour will be considered as an event:
If A-Fib is present for more than accumulated 5 minutes in that specific hour then it shall be considered an "A-Fib hour" If A-fib was present for less than accumulated 5 minutes then it shall be considered a "Non-A-Fib hour".
For ECG analysis, each measurement of between 1-3 minutes will be considered an event.
If A-Fib is present at that specific measurement, then it shall be considered an "A-Fib event" If A-fib was not present at that specific measurement, then it shall be considered a "Non-A-Fib hour".
Sensitivity (true positive) is defined as the percentage of Holter defined "A-fib hours"/"A-Fib event" found by PPG/ECG.
The asked sensitivity is 90%. Specificity (true negative) is defined as the percentage of Holter defined "Non-A-fib hours"/"A-Fib event" found by PPG/ECG. The required specificity is 90%.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Males and females, 50 of them diagnosed with atrial fibrillation (AF), and 50 healthy participants, at least 30% of each gender in each group.
| Arm | Type | Receives |
|---|---|---|
| CS1 & heart monitor - AF patients | Experimental | Device: CS1 & heart monitorMales and females diagnosed with atrial fibrillation will be fitted with the CardiacSense1 and Holter heart monitor for 24-48 hours while going about daily activities, results shall be compared and analysed |
| CS1 & heart monitor -Healthy volunteers | Active comparator | Device: CS1 & heart monitorMales and females not diagnosed with atrial fibrillation will be fitted with the CardiacSense1 and Holter heart monitor for 24-48 hours while going about daily activities, results shall be compared and analysed |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age of eighteen (18) year and above
- Diagnosed with atrial fibrilation (Permanent of persistent), or healthy participants able to and willing to sign the informed consent form For control group-no known cardiac problems
Key exclusion criteria (3 listed)
- Subjects who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the subject's participation in this study.
- Subjects with low perfusion as indicated by the watch
- Women who are pregnant or breastfeeding
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 |
|---|---|---|
| CS1 & heart monitorDaily activities while wearing the investigational device as well as the control device | Device | CS1 & heart monitor - AF patients, CS1 & heart monitor -Healthy volunteers |
Primary outcome
CardicacSense1 atrial fibrillation detection rate
Time frame: 24 to 48 hours
Comparison of the number of atrial fibrillation sessions detected by reference comparing to PPG and ECG sensors in CardiacSense device.
Safety of CardicacSense1
Time frame: 24 to 48 hours
Incidence and severity of device related Adverse Events
1 secondary outcome
Usability
Time frame: 24 to 48 hours
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 21 Jul 2020.
- Individual participant dataSharing planned: No. No individual data will be shared. Data analysis will include comparative overall data between investigational device and control device, as well as usability data
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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.
Ofer Havakuk, MD, PhD principal investigator
Department of Cardiology, Tel Aviv Medical Center and Sackler School of Medicine, Tel Aviv University, Israel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CS1 & heart monitor in people with Atrium; Fibrillation, run by CardiacSense Ltd. at 2 sites 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 2 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 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
CardicacSense1 atrial fibrillation detection rate (time frame: 24 to 48 hours). 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 21 Jul 2020.