Atrial FibrillationC4RNCT06091514
Connected Cardiology to Control Cardiac Rythm
A study testing CS Medical Watch and Specific questionnaire in people with Atrial Fibrillation, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
New-onset of atrial fibrillation (AF) and atrial arrythmia (AA) in general, is important as it exposes patients to stroke or other embolic complications not to mention the risk of heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- CS Medical Watch and Specific questionnaire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Feb 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 18 years or more
- Patient having signed free, informed, and written consent
- Patient presenting one of the following situations :
- Post-stroke or TIA patient with an already in place ILR
- Patient with symptoms evocative of AF (e.g. increased heart rate, chest pain) with an already in place ILR
- Post-PFO closure patient with an already in place ILR
Show all 9Show fewer
- Patient in sinus rhythm treated for the prevention of paroxysmal AF with an already in place ILR
- Patient at high risk of AF (at the discretion of the investigator) with an already in place ILR
- Patient with a period of risk of AF ≥ 3 months.
Who cannot join
- Patient under legal protection
- Pregnant and/or breastfeeding women
- Patient with pacemakers, or ICD
- Patient with blood flow deficiency-related conditions
- Patient with tattoo or injured skin on the wrist
- Patient with tremors or otherwise unable to remain still for 15 minutes
- Patient without two hands and sufficient fingers to complete the study.
About this study
New-onset of atrial fibrillation (AF) and atrial arrythmia (AA) in general, is important as it exposes patients to stroke or other embolic complications not to mention the risk of heart failure. AF detection in high risk populations such as patients with a recent stroke or TIA or, symptomatic patients with multiple risk factors for AF, is performed with long-term electrocardiography monitoring using frequently implantable loop recorders (ILR). These recorders have their own limitations related to the invasive nature of the device implanted under the skin of the chest with limited acceptation by the patients. Smart watches appear as useful alternatives, but they need to be evaluated in an all-comer population of patients highly exposed to AF, different from the large population studies conducted in healthy young adults with a low incidence of AF. The unique features of CardiacSense Medical System suggest that we could have an accurate noninvasive detection of AF in a selected population very much exposed to the risk of atrial fibrillation, the most frequent atrial arrhythmia.
Read the detailed description
Study design :
This clinical investigation is a comparative, non-randomised, one group, controlled study.
Each patient represents its own control. The study will envolve 400 participants
Hypothesis :
Our hypothesis is that CardiacSense Medical System is an effective, safe, and better accepted alternative for detecting atrial fibrillation (AF) in a high-risk population than implantable loop recorders (ILRs).
Population :
Any patient aged 18 years or more, with an ILR implanted for the detection of AF will be eligible. The time of implantation will not matter as long as the batteries work. Each patient will be proposed a CS Medical Watch for a period corresponding to the period at risk of AF.
Main objective :
To compare the performance of the CardiacSense Medical Watch by pulse plethysmography (PPG) only to the gold standard method of ILR monitoring, to detect AF that lasts 5 minutes or more, in a population of patients at high risk of paroxysmal AF.
- Conditions
- Atrial Fibrillation
- Being tested
- CS Medical Watch, Specific questionnaire
- Keywords
- Connected Watch, Atrial Fibrilation (AF), Atrial Arythmia AA, Implantable Loop Recorder (ILR)
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS Medical WatchDevice
The Use of the CS Medical Watch during the participation period of the clinical investigation (between 3 and 12 months according to the period at risk of AF).
Specific questionnaireOther
Specific questionnaire during the last study visit (takes place at M3 to M12 according to the period at risk of AF)
| Study group | Role | What they receive |
|---|---|---|
| Cohort group | Other | Patients will be followed during a period ranging from 3 to 12 months depending on his period at risk of AF. This period will be defined at the inclusion visit. During this period, the patient will be followed as part of usual care, considering the medical informations given by the ILR device already implanted.
During this period, the patient will have to wear the watch permanently outside charging time. Moreover, he will have to realize ECG measurement when the Medical Watch will indicate it. The patient could also trigger an ECG measurement if he feels the need. Receives: Device: CS Medical Watch; Other: Specific questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total number of episodes AF that lasts 5 min or more recorded on long-term monitoring
The total number of episodes AF that lasts 5 min or more recorded on long-term monitoring using the CardiacSense Medical Watch by pulse plethysmography (PPG) only vs the gold standard method of ILR ECG recording, over the same period of monitoring by the two devices for each patient.
Measured: between 3 and 12 months according to the period at risk of AF
Secondary outcomes (6)
The total number of AA episodes that lasts 5 min or more recorded on long-term monitoring
The total number of AA episodes that lasts 5 min or more detected by PPG and confirmed by ECG measurement of the CardiacSense Medical Watch (vs. ILR ECG recording) over the same period of monitoring by the two devices for each patient.
Measured: between 3 and 12 months according to the period at risk of AF
The total number of episodes AF that lasts 5 min or more recorded on long-term monitoring
Same primary endpoint for symptomatic patients vs. asymptomatic patients
Measured: between 3 and 12 months according to the period at risk of AF
The total duration of AF episodes that lasts 5 min or more
Total duration of AF episodes that lasts 5 min or more / total duration of monitoring expressed in % for each device (PPG CS watch only vs. ILR ECG recording).
Measured: between 3 and 12 months according to the period at risk of AF
Incidence and severity of CS device vs ILR devices
Related Adverse Events and incidents during the patient participation
Measured: between 3 and 12 months according to the period at risk of AF
Degree of invasiveness, comfort, and ease of use of both devices
Description : measured using specific questionnaires for the study
Measured: between 3 and 12 months according to the period at risk of AF
Medico-economic evaluation according to the AP-HP hospital costs
- The cost of each medical device (considering the replacement when needed over the study period for each patient)
- The cost for extra-consultation/hospitalization for surgery, complication, or education.
Measured: between 3 and 12 months according to the period at risk of AF
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study startFeb 2024 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Why it stopped: Decision by the manufacturer
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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- This clinical investigation is a comparative, one group, controlled study. Each patient represents its own control. Patients with an ILR already implanted for the detection of AF will receive a CS Medical Watch for a period corresponding to the period at risk of AF, up to 1 year maximum. For each patient, results obtained with the ILR device will be compared to results obtained with the CS Medical Watch device. During the conduct of the study, all medical decisions will be taken according to the ILR already implanted. No medical decision will be taken on CardiacSense System information collected during the study.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Action Research Group, Hôpital Lariboisière Fernand Widal
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091514
- Sponsor's protocol ID
- APHP230642
- Acronym
- C4R
- Status last verified
- Aug 2026
- First submitted
- 16 Oct 2023
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connected Cardiology to Control Cardiac Rythm
- ClinicalTrials.gov ID
- NCT06091514
- Acronym / sponsor ID
- C4R / APHP230642
- Conditions
- Atrial Fibrillation
- Keywords
- Connected Watch, Atrial Fibrilation (AF), Atrial Arythmia AA, Implantable Loop Recorder (ILR)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Decision by the manufacturer
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Action Research Group, Hôpital Lariboisière Fernand Widal
- Study start
- Feb 2024 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 19 Oct 2023 (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.
New-onset of atrial fibrillation (AF) and atrial arrythmia (AA) in general, is important as it exposes patients to stroke or other embolic complications not to mention the risk of heart failure. AF detection in high risk populations such as patients with a recent stroke or TIA or, symptomatic patients with multiple risk factors for AF, is performed with long-term electrocardiography monitoring using frequently implantable loop recorders (ILR). These recorders have their own limitations related to the invasive nature of the device implanted under the skin of the chest with limited acceptation by the patients. Smart watches appear as useful alternatives, but they need to be evaluated in an all-comer population of patients highly exposed to AF, different from the large population studies conducted in healthy young adults with a low incidence of AF. The unique features of CardiacSense Medical System suggest that we could have an accurate noninvasive detection of AF in a selected population very much exposed to the risk of atrial fibrillation, the most frequent atrial arrhythmia.
Detailed description
Study design :
This clinical investigation is a comparative, non-randomised, one group, controlled study.
Each patient represents its own control. The study will envolve 400 participants
Hypothesis :
Our hypothesis is that CardiacSense Medical System is an effective, safe, and better accepted alternative for detecting atrial fibrillation (AF) in a high-risk population than implantable loop recorders (ILRs).
Population :
Any patient aged 18 years or more, with an ILR implanted for the detection of AF will be eligible. The time of implantation will not matter as long as the batteries work. Each patient will be proposed a CS Medical Watch for a period corresponding to the period at risk of AF.
Main objective :
To compare the performance of the CardiacSense Medical Watch by pulse plethysmography (PPG) only to the gold standard method of ILR monitoring, to detect AF that lasts 5 minutes or more, in a population of patients at high risk of paroxysmal AF.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This clinical investigation is a comparative, one group, controlled study. Each patient represents its own control. Patients with an ILR already implanted for the detection of AF will receive a CS Medical Watch for a period corresponding to the period at risk of AF, up to 1 year maximum. For each patient, results obtained with the ILR device will be compared to results obtained with the CS Medical Watch device. During the conduct of the study, all medical decisions will be taken according to the ILR already implanted. No medical decision will be taken on CardiacSense System information collected during the study.
| Arm | Type | Receives |
|---|---|---|
| Cohort group | Other | Device: CS Medical Watch, Other: Specific questionnairePatients will be followed during a period ranging from 3 to 12 months depending on his period at risk of AF. This period will be defined at the inclusion visit. During this period, the patient will be followed as part of usual care, considering the medical informations given by the ILR device already implanted. During this period, the patient will have to wear the watch permanently outside charging time. Moreover, he will have to realize ECG measurement when the Medical Watch will indicate it. The patient could also trigger an ECG measurement if he feels the need. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient aged 18 years or more
- Patient having signed free, informed, and written consent
- Patient presenting one of the following situations :
- Post-stroke or TIA patient with an already in place ILR
- Patient with symptoms evocative of AF (e.g. increased heart rate, chest pain) with an already in place ILR
Key exclusion criteria (7 listed)
- Patient under legal protection
- Pregnant and/or breastfeeding women
- Patient with pacemakers, or ICD
- Patient with blood flow deficiency-related conditions
- Patient with tattoo or injured skin on the wrist
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 |
|---|---|---|
| CS Medical WatchThe Use of the CS Medical Watch during the participation period of the clinical investigation (between 3 and 12 months according to the period at risk of AF). | Device | Cohort group |
| Specific questionnaireSpecific questionnaire during the last study visit (takes place at M3 to M12 according to the period at risk of AF) | Other | Cohort group |
Primary outcome
The total number of episodes AF that lasts 5 min or more recorded on long-term monitoring
Time frame: between 3 and 12 months according to the period at risk of AF
The total number of episodes AF that lasts 5 min or more recorded on long-term monitoring using the CardiacSense Medical Watch by pulse plethysmography (PPG) only vs the gold standard method of ILR ECG recording, over the same period of monitoring by the two devices for each patient.
6 secondary outcomes
The total number of AA episodes that lasts 5 min or more recorded on long-term monitoring
Time frame: between 3 and 12 months according to the period at risk of AF
The total number of episodes AF that lasts 5 min or more recorded on long-term monitoring
Time frame: between 3 and 12 months according to the period at risk of AF
The total duration of AF episodes that lasts 5 min or more
Time frame: between 3 and 12 months according to the period at risk of AF
Incidence and severity of CS device vs ILR devices
Time frame: between 3 and 12 months according to the period at risk of AF
Degree of invasiveness, comfort, and ease of use of both devices
Time frame: between 3 and 12 months according to the period at risk of AF
Medico-economic evaluation according to the AP-HP hospital costs
Time frame: between 3 and 12 months according to the period at risk of AF
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing CS Medical Watch and Specific questionnaire in people with Atrial Fibrillation, run by Assistance Publique - Hôpitaux de Paris.
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 9 inclusion and 7 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: withdrawn, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
The total number of episodes AF that lasts 5 min or more recorded on long-term monitoring (time frame: between 3 and 12 months according to the period at risk of AF). 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 25 Aug 2026; AzTrials last refreshed its copy on 1 Nov 2026.