Atrial Fibrillation (AF)COR-AFNCT06955273
Multi-Centre Based Study Recognition of Atrial Fibrillation With the Corsano CardioWatch 287-2 System
An observational study of Atrial Fibrillation (AF) and Paroxysmal Atrial Fibrillation (PAF), run by Corsano Health B.V. at 1 site in Netherlands.
Trial summary
This concerns a multi-center, single-arm, diagnostic accuracy study. In this study, a wristband that monitors heart rythm is assessed in clinical and free living conditions. The performance of the wristband in detecting atrial fibrillation and normal sinus rhythms will be compared to a short 12-lead ECG or 24-hour… Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation (AF), Paroxysmal Atrial Fibrillation (PAF)
- What is being tested?
- Corsano CardioWatch 287-2
- Type of treatment
- Medical device
- How many people
- 350 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 May 2025to Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population for groups A-B-D includes patients visiting the outpatient clinic of at least 4 different hospitals, of which one is located in the Netherlands (Reinier de Graaf Gasthuis, Delft) and three are located in different locations across the USA. GROUP A Patients receiving an ECG holter at the outpatient clinic for 24 hours of remote monitoring (standard of care) GROUP B Patients diagnosed with (paroxysmal) AF presenting to the clinic for routine follow-up evaluation (NOT necessarily standard of care) GROUP C Patients diagnosed with (paroxysmal) AF registered in a patient organisation for patients with AF (standard of care) GROUP D Patients receiving a 12-lead ECG at the outpatient clinic as standard of care (NOT standard of care)
Who may be able to join
- Patients with symptoms indicative of cardiac arrhythmias receiving 24-48 hour ECG holter for home monitoring or in-clinic 12-lead ECG per doctor prescription OR previous diagnosis of arrhythmia presenting to the clinic for routine follow-up evaluation
- Age ≥ 22 years old
- Able to provide informed consent.
- Proficient in written and spoken Dutch or English, defined by self-report of comfort reading, writing, and speaking Dutch or English.
Who cannot join
- Clinical conditions that in the opinion of the Investigator would compromise the safety of the patient or ability to complete the protocol;
- Unable to wear the Corsano CardioWatch 287 due to reasons such as allergic reactions, wounds, amputations etc.;
- Unable or not willing to receive ECG monitoring;
- Unable or not willing to sign informed consent;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Reinier de Graaf Gasthuis
Delft, South Holland, 2625AD
Eelko Ronner, MD, PhD, 015 - 260 33 20 ext. +31, eronner@rdgg.nl
About this study
This concerns a multi-center, single-arm, diagnostic accuracy study. In this study, a wristband that monitors heart rythm is assessed in clinical and free living conditions. The performance of the wristband in detecting atrial fibrillation and normal sinus rhythms will be compared to a short 12-lead ECG or 24-hour holter.
To ensure that both patients with and without atrial fibrillation are included whilst limiting the burden on patients and hospital staff, four groups of patients are being recruited:
Read more
- Group A: patients receiving an ECG holter at the outpatient clinic for 24-48 hours of remote monitoring
- Group B: patients diagnosed with (paroxysmal) AF presenting to the clinic for routine follow-up evaluation.
- Group C: patients diagnosed with (paroxysmal) AF registered in a patient organisation for patients with AF.
- Group D: patients receiving a 12-lead ECG at the outpatient clinic as standard of care.
The secondary outcomes of the study focus on assessing the primary outcomes in light of demographic subgroups, patient physical activity and the signal quality index.
Read the detailed description
Rationale:
Wearables have the potential to monitor patients remotely. The Corsano CardioWatch 287-2 is such a medical device that can monitor atrial fibrillation. The device has been validated using clinical trials in hospitals, but evaluation in the intended remote setting across various demographic groups is lacking.
Primary objective:
To compare episodes of atrial fibrillation across 30-second intervals detected by the Corsano CardioWatch 287-2 with episodes of atrial fibrillation detected by conventional Holter monitoring across 24-48 hours or short in-clinic 12-lead ECG based on the positive predictive value, negative predictive value, sensitivity and specificity.
Secondary objective: To compare the number of atrial fibrillation episodes greater than 6 minutes, 1 hour, 6 hours, and 12 hours duration detected by the CardioWatch 287-2 and with the number of these specific episodes detected by conventional Holter across 24-48 hours days. As well as to assess primary outcomes in light of demographic subgroups, patient activity and the signal quality index.
Study population:
One group (A) receiving an ECG monitoring holter for the duration of 24-48 hours days as part of standard care for atrial fibrillation screening. Besides, one group (B) diagnosed with (paroxysmal) without indication for holter monitoring according to standard of care AF presenting to the clinic for routine follow-up evaluation. Adding, one group (C) diagnosed with (paroxysmal) and registered in a patient organisation for patients with AF. Finally, one group (D) receiving in-clinic 12-lead ECG monitoring as part of standard of care.
Study design:
This concerns a multi-center, single-arm, diagnostic accuracy study.
Four different groups of patients will be approached for participation in the trial:
- Group A: patients receiving an ECG holter at the outpatient clinic for 24-48 hours of remote monitoring
- Group B: patients diagnosed with (paroxysmal) AF presenting to the clinic for routine follow-up evaluation.
- Group C: patients diagnosed with (paroxysmal) AF registered in a patient organisation for patients with AF.
- Group D: patients receiving a 12-lead ECG at the outpatient clinic as standard of care.
Groups A, B and C will receive ECG holter monitoring as well as continuous monitoring by the Corsano CardioWatch 287-2 across 24-48 hours to assess whether the amount and duration of AF episodes detected by the investigational device correspond to the gold standard. Detection of atrial fibrillation with the Corsano CardioWatch 287-2 is done by optical photoplethysmography (PPG), after which atrial fibrillation can be confirmed with a 30-second ECG measurement. Additionally, all participants will be asked to perform 10 single-lead ECG's at standard timepoints (approx. every 2 hours when awake) across the 24-48 hours as well as additional ECG measurements in case of AF (at least 30 minutes between alerts). Group B was added to ensure that a considerable amount of the included data includes periods with atrial fibrillation. As the results of a prior study (RECAMO study NL NL83281.000.22) show that the amount of patients in Group A with periods of atrial fibrillation is limited (7.0%). Furthermore, Group C was added to limit the additional workload for hospital staff and ensure inclusion of a diverse patient population from different demographic and ethnical groups. For this group two (virtual) visits will be scheduled before and after the study period to detect any alarming signals before participation in the study and to share and explain the results after study completion. Finally, group D, a group receiving a short in-clinic 12-lead ECG as standard of care was added to ensure the inclusion of a broad and sizable demographic group whilst keeping the burden on the patient and hospital staff limited.
- Being tested
- Corsano CardioWatch 287-2
- Keywords
- wristband, wearable, atrial fibrillation, holter, ecg, remote monitoring, validation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corsano CardioWatch 287-2Device
Patients receive monitoring of their heart rhythm by the CardioWatch 287-2 next to monitoring of their heart rhythm by either a 24-48 holter or a short in-clinic 12-lead ECG monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Group A: patients receiving 24-48 hour holter monitoring as standard of care | Holter monitoring will be compared to continuous monitoring by the Corsano CardioWatch 287-2 across 24-48 hours to assess whether the amount and duration of AF episodes detected by the investigational device correspond to an ECG-holter reference across various demographic groups. Detection of atrial fibrillation with the Corsano CardioWatch 287-2 is done by optical photoplethysmography (PPG), after which atrial fibrillation can be confirmed with a 30-second ECG measurement. Additionally, all participants will be asked to perform 10 single-lead ECG's with the investigational device at standard timepoints (every 2 hours when awake), and when AF is detected (minimal 30 minutes time difference between alerts) across the 24-48 hours. Receives: Device: Corsano CardioWatch 287-2 | |
| Group B: patients diagnosed with (paroxysmal) AF presenting to the clinic for routine follow-up | Patients with a known diagnosis of (paroxysmal) atrial fibrillation presenting to the clinic for routine follow-up evaluation will be asked to eligibly participate in ECG-holter monitoring as well as continuous monitoring by the Corsano CardioWatch 287-2 across 24-48 hours. Similar to group A, these patients will also be asked to perform manual ECG measurements with the investigational device. Group B was added to ensure that a considerable amount of the included data includes periods with atrial fibrillation. As the results of a prior study (RECAMO study NCT05899959) show that the amount of patients in Group A with periods of atrial fibrillation is limited (7.0%). Receives: Device: Corsano CardioWatch 287-2 | |
| Group C: patients diagnosed with (paroxysmal) AF registered in a patient organisation | Patients with a known diagnosis of (paroxysmal) atrial fibrillation registered in a patient organisation for patients with AF will be asked to eligibly participate in ECG-holter monitoring as well as continuous monitoring by the Corsano CardioWatch 287-2 across 24-48 hours. Similar to group A and B, these patients will also be asked to perform manual ECG measurements with the investigational device. For this group two (virtual) visits will be scheduled before (visit a) and after (visit b) the study period. In visit a) additional information regarding the study will be provided and potential alarm signals will be screened to ensure the patient does not participate in the trial in case direct medical attention is required. If the patient does not show any alarm signals they will be asked to provide informed consent. Once informed consent is provided all materials will be mailed to them via postal services after which they can perform the measurements and return the materials via postal Receives: Device: Corsano CardioWatch 287-2 | |
| Group D: patients receiving a 12-lead ECG at the outpatient clinic as standard of care. | Participants in this group will wear the CardioWatch 287-2 during the standard 12-lead ECG recordings conducted in the outpatient clinic. Patients will be asked to perform a manual ECG spot-check with the investigational device during (if not feasible directly before), and immediately following the 12-lead ECG. Furthermore, the CardioWatch 287-2 will be worn for at least 5 minutes prior to and following the 12-lead ECG. Although these recordings are brief, this group was included to enhance the study population's size and demographic diversity while minimizing the burden on both patients and hospital staff. This group is expected to consist of both non-AF and AF patients, providing valuable insights into the investigational device's performance in a setting similar to its intended real-world application. Receives: Device: Corsano CardioWatch 287-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation detection across 30-second intervals by CardioWatch PPG algorithm vs. 24-48 hour Holter
The absolute number of detected AF 30-second intervals by the CardioWatch's PPG algorithm will be determined and compared to the reference ECG holter monitoring, by means of calculating the positive predictive value (PPV), negative predictive value (NPV), specificity, and sensitivity. Performance goals for PPV and NPV are ≥90%, and performance goals for sensitivity and specificity are ≥95%.
Measured: From enrollment up to 48 hours
Atrial fibrillation detection across 30-second intervals by CardioWatch PPG algorithm vs. short in-clinic 12-lead ECG
The absolute number of detected AF 30-second intervals by the CardioWatch's PPG algorithm will be determined and compared to the reference in-clinic 12-lead ECG, by means of calculating the positive predictive value (PPV), negative predictive value (NPV), specificity, and sensitivity. Performance goals for PPV and NPV are ≥90%, and performance goals for sensitivity and specificity are ≥95%.
Measured: From enrollment up to 30 minutes
Atrial fibrillation detection across 30-second intervals by CardioWatch single-lead ECG vs. 24-48 hour Holter
The absolute number of detected AF by the CardioWatch's single-lead ECG algorithm will be determined and compared to the reference ECG holter monitoring at the most similar moment in time by means of calculating the PPV, NPV, specificity, and sensitivity for timestamps corresponding to the single-lead spot checks.
Measured: From enrollment up to 48 hours
Atrial fibrillation detection across 30-second intervals by CardioWatch single-lead ECG vs. short in-clinic 12-lead ECG
The absolute number of detected AF by the CardioWatch's single-lead ECG algorithm will be determined and compared to the reference in-clinic ECG at the most similar moment in time by means of calculating the PPV, NPV, specificity, and sensitivity for timestamps corresponding to the single-lead spot checks.
Measured: From enrollment up to 30 minutes
Secondary outcomes (11)
Correspondence between cases with AF of greater than 6 minutes, 1 hour, 6 hours, and 12 hours
Correspondence between cases with AF of greater than 6 minutes, 1 hour, 6 hours, and 12 hours duration detected by the ECG Holter monitor and the CardioWatch's PPG-algorithm, provided as a percentage of the total cases registered by the ECG Holter monitor for each duration as determined by the Clinical Adjudication Committee (CAC).
Measured: From enrollment up to 48 hours
Compliance with ECG alerts
Compliance with ECG alerts during at home holter-monitoring, together with:
Measured: From enrollment up to 48 hours
Amount of ECG attempts before successful ECG
Amount of ECG attempts before successful ECG during at home holter-monitoring
Measured: From enrollment up to 48 hours
Confirmation of AF by single-lead ECG
The confirmation of AF: single-lead ECG vs PPG-based (ECGs within one hour of alert)
Measured: From enrollment up to 48 hours
RMSE of HR measurement and reference
The root mean square error (RMSE) between the single-lead ECG heart rate (HR) and reference ECG holter HR.
Measured: From enrollment up to 48 hours
Atrial fibrillation detection performance for males vs. females
Atrial fibrillation detection performance determined for subgroups of males and females individually.
Measured: Baseline information gathered during enrollment
Atrial fibrillation detection performance for BMI subgroups
Atrial fibrillation detection performance determined for subgroups of BMI: Underweight (<18.5); Normal weight (18.5-24.9); Overweight (25-29.9); Obese (≥30).
Measured: Baseline information gathered during enrollment
Atrial fibrillation detection performance for skin colour based subgroups
Atrial fibrillation detection performance determined for subgroups of Skin colour: Monk skin tone (MST) scale 1-3; MST 4-6; MST 7-10. (Researcher will compare reference colors in scale as described in Monk et al. (2023) to the skin of participants)
Measured: Baseline information gathered during enrollment
Atrial fibrillation detection performance for ethinicity based subgroups
Atrial fibrillation detection performance determined for subgroups of Ethnicity: Caucasian; African American; Asian; Hispanic/Latino.
According to FDA recommendations at least 30 patients total, 15 AF patients and 15 NSR patients, need to be included at each of the subgroup levels of Monk skin tone, ethnicity, sex, BMI. After enrolment of 150 patients, accounting of the subgroups will be considered, and further enrolment will be restricted to ensure minimal distributions of each subgroup level are enrolled, specifically focusing on enrollments in study group D.
Measured: Baseline information gathered during enrollment
Atrial fibrillation detection performance in light of patient activity
Atrial fibrillation detection performance for subgroups based on patient activity using ACC: motion; resting; standing
Measured: From enrollment up to 48 hours
Atrial fibrillation detection performance in light of signal quality index
Atrial fibrillation detection performance relative to the signal quality index.
Measured: From enrollment up 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 posted2 May 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corsano Health B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eelko Ronner, MD, PhD, Principal investigator, Reinier de Graaf Groep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955273
- Sponsor's protocol ID
- COR-AF
- Acronym
- COR-AF
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 2 May 2025
- 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 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Centre Based Study Recognition of Atrial Fibrillation With the Corsano CardioWatch 287-2 System
- ClinicalTrials.gov ID
- NCT06955273
- Acronym / sponsor ID
- COR-AF / COR-AF
- Keywords
- wristband, wearable, atrial fibrillation, holter, ecg, remote monitoring, validation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Corsano Health B.V.Industry (pharma, biotech, devices)
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 2 May 2025 (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.
This concerns a multi-center, single-arm, diagnostic accuracy study. In this study, a wristband that monitors heart rythm is assessed in clinical and free living conditions. The performance of the wristband in detecting atrial fibrillation and normal sinus rhythms will be compared to a short 12-lead ECG or 24-hour holter.
To ensure that both patients with and without atrial fibrillation are included whilst limiting the burden on patients and hospital staff, four groups of patients are being recruited:
- Group A: patients receiving an ECG holter at the outpatient clinic for 24-48 hours of remote monitoring
- Group B: patients diagnosed with (paroxysmal) AF presenting to the clinic for routine follow-up evaluation.
- Group C: patients diagnosed with (paroxysmal) AF registered in a patient organisation for patients with AF.
- Group D: patients receiving a 12-lead ECG at the outpatient clinic as standard of care.
The secondary outcomes of the study focus on assessing the primary outcomes in light of demographic subgroups, patient physical activity and the signal quality index.
Detailed description
Rationale:
Wearables have the potential to monitor patients remotely. The Corsano CardioWatch 287-2 is such a medical device that can monitor atrial fibrillation. The device has been validated using clinical trials in hospitals, but evaluation in the intended remote setting across various demographic groups is lacking.
Primary objective:
To compare episodes of atrial fibrillation across 30-second intervals detected by the Corsano CardioWatch 287-2 with episodes of atrial fibrillation detected by conventional Holter monitoring across 24-48 hours or short in-clinic 12-lead ECG based on the positive predictive value, negative predictive value, sensitivity and specificity.
Secondary objective: To compare the number of atrial fibrillation episodes greater than 6 minutes, 1 hour, 6 hours, and 12 hours duration detected by the CardioWatch 287-2 and with the number of these specific episodes detected by conventional Holter across 24-48 hours days. As well as to assess primary outcomes in light of demographic subgroups, patient activity and the signal quality index.
Study population:
One group (A) receiving an ECG monitoring holter for the duration of 24-48 hours days as part of standard care for atrial fibrillation screening. Besides, one group (B) diagnosed with (paroxysmal) without indication for holter monitoring according to standard of care AF presenting to the clinic for routine follow-up evaluation. Adding, one group (C) diagnosed with (paroxysmal) and registered in a patient organisation for patients with AF. Finally, one group (D) receiving in-clinic 12-lead ECG monitoring as part of standard of care.
Study design:
This concerns a multi-center, single-arm, diagnostic accuracy study.
Four different groups of patients will be approached for participation in the trial:
- Group A: patients receiving an ECG holter at the outpatient clinic for 24-48 hours of remote monitoring
- Group B: patients diagnosed with (paroxysmal) AF presenting to the clinic for routine follow-up evaluation.
- Group C: patients diagnosed with (paroxysmal) AF registered in a patient organisation for patients with AF.
- Group D: patients receiving a 12-lead ECG at the outpatient clinic as standard of care.
Groups A, B and C will receive ECG holter monitoring as well as continuous monitoring by the Corsano CardioWatch 287-2 across 24-48 hours to assess whether the amount and duration of AF episodes detected by the investigational device correspond to the gold standard. Detection of atrial fibrillation with the Corsano CardioWatch 287-2 is done by optical photoplethysmography (PPG), after which atrial fibrillation can be confirmed with a 30-second ECG measurement. Additionally, all participants will be asked to perform 10 single-lead ECG's at standard timepoints (approx. every 2 hours when awake) across the 24-48 hours as well as additional ECG measurements in case of AF (at least 30 minutes between alerts). Group B was added to ensure that a considerable amount of the included data includes periods with atrial fibrillation. As the results of a prior study (RECAMO study NL NL83281.000.22) show that the amount of patients in Group A with periods of atrial fibrillation is limited (7.0%). Furthermore, Group C was added to limit the additional workload for hospital staff and ensure inclusion of a diverse patient population from different demographic and ethnical groups. For this group two (virtual) visits will be scheduled before and after the study period to detect any alarming signals before participation in the study and to share and explain the results after study completion. Finally, group D, a group receiving a short in-clinic 12-lead ECG as standard of care was added to ensure the inclusion of a broad and sizable demographic group whilst keeping the burden on the patient and hospital staff limited.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A: patients receiving 24-48 hour holter monitoring as standard of care | – | Device: Corsano CardioWatch 287-2Holter monitoring will be compared to continuous monitoring by the Corsano CardioWatch 287-2 across 24-48 hours to assess whether the amount and duration of AF episodes detected by the investigational device correspond to an ECG-holter reference across various demographic groups. Detection of atrial fibrillation with the Corsano CardioWatch 287-2 is done by optical photoplethysmography (PPG), after which atrial fibrillation can be confirmed with a 30-second ECG measurement. Additionally, all participants will be asked to perform 10 single-lead ECG's with the investigational device at standard timepoints (every 2 hours when awake), and when AF is detected (minimal 30 minutes time difference between alerts) across the 24-48 hours. |
| Group B: patients diagnosed with (paroxysmal) AF presenting to the clinic for routine follow-up | – | Device: Corsano CardioWatch 287-2Patients with a known diagnosis of (paroxysmal) atrial fibrillation presenting to the clinic for routine follow-up evaluation will be asked to eligibly participate in ECG-holter monitoring as well as continuous monitoring by the Corsano CardioWatch 287-2 across 24-48 hours. Similar to group A, these patients will also be asked to perform manual ECG measurements with the investigational device. Group B was added to ensure that a considerable amount of the included data includes periods with atrial fibrillation. As the results of a prior study (RECAMO study NCT05899959) show that the amount of patients in Group A with periods of atrial fibrillation is limited (7.0%). |
| Group C: patients diagnosed with (paroxysmal) AF registered in a patient organisation | – | Device: Corsano CardioWatch 287-2Patients with a known diagnosis of (paroxysmal) atrial fibrillation registered in a patient organisation for patients with AF will be asked to eligibly participate in ECG-holter monitoring as well as continuous monitoring by the Corsano CardioWatch 287-2 across 24-48 hours. Similar to group A and B, these patients will also be asked to perform manual ECG measurements with the investigational device. For this group two (virtual) visits will be scheduled before (visit a) and after (visit b) the study period. In visit a) additional information regarding the study will be provided and potential alarm signals will be screened to ensure the patient does not participate in the trial in case direct medical attention is required. If the patient does not show any alarm signals they will be asked to provide informed consent. Once informed consent is provided all materials will be mailed to them via postal services after which they can perform the measurements and return the materials via postal |
| Group D: patients receiving a 12-lead ECG at the outpatient clinic as standard of care. | – | Device: Corsano CardioWatch 287-2Participants in this group will wear the CardioWatch 287-2 during the standard 12-lead ECG recordings conducted in the outpatient clinic. Patients will be asked to perform a manual ECG spot-check with the investigational device during (if not feasible directly before), and immediately following the 12-lead ECG. Furthermore, the CardioWatch 287-2 will be worn for at least 5 minutes prior to and following the 12-lead ECG. Although these recordings are brief, this group was included to enhance the study population's size and demographic diversity while minimizing the burden on both patients and hospital staff. This group is expected to consist of both non-AF and AF patients, providing valuable insights into the investigational device's performance in a setting similar to its intended real-world application. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population for groups A-B-D includes patients visiting the outpatient clinic of at least 4 different hospitals, of which one is located in the Netherlands (Reinier de Graaf Gasthuis, Delft) and three are located in different locations across the USA. GROUP A Patients receiving an ECG holter at the outpatient clinic for 24 hours of remote monitoring (standard of care) GROUP B Patients diagnosed with (paroxysmal) AF presenting to the clinic for routine follow-up evaluation (NOT necessarily standard of care) GROUP C Patients diagnosed with (paroxysmal) AF registered in a patient organisation for patients with AF (standard of care) GROUP D Patients receiving a 12-lead ECG at the outpatient clinic as standard of care (NOT standard of care)
Key inclusion criteria (4 listed)
- Patients with symptoms indicative of cardiac arrhythmias receiving 24-48 hour ECG holter for home monitoring or in-clinic 12-lead ECG per doctor prescription OR previous diagnosis of arrhythmia presenting to the clinic for routine follow-up evaluation
- Age ≥ 22 years old
- Able to provide informed consent.
- Proficient in written and spoken Dutch or English, defined by self-report of comfort reading, writing, and speaking Dutch or English.
Key exclusion criteria (4 listed)
- Clinical conditions that in the opinion of the Investigator would compromise the safety of the patient or ability to complete the protocol;
- Unable to wear the Corsano CardioWatch 287 due to reasons such as allergic reactions, wounds, amputations etc.;
- Unable or not willing to receive ECG monitoring;
- Unable or not willing to sign informed consent;
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 |
|---|---|---|
| Corsano CardioWatch 287-2Patients receive monitoring of their heart rhythm by the CardioWatch 287-2 next to monitoring of their heart rhythm by either a 24-48 holter or a short in-clinic 12-lead ECG monitoring. | Device | Group A: patients receiving 24-48 hour holter monitoring as standard of care, Group B: patients diagnosed with (paroxysmal) AF presenting to the clinic for routine follow-up, Group C: patients diagnosed with (paroxysmal) AF registered in a patient organisation, Group D: patients receiving a 12-lead ECG at the outpatient clinic as standard of care. |
Primary outcome
Atrial fibrillation detection across 30-second intervals by CardioWatch PPG algorithm vs. 24-48 hour Holter
Time frame: From enrollment up to 48 hours
The absolute number of detected AF 30-second intervals by the CardioWatch's PPG algorithm will be determined and compared to the reference ECG holter monitoring, by means of calculating the positive predictive value (PPV), negative predictive value (NPV), specificity, and sensitivity. Performance goals for PPV and NPV are ≥90%, and performance goals for sensitivity and specificity are ≥95%.
Atrial fibrillation detection across 30-second intervals by CardioWatch PPG algorithm vs. short in-clinic 12-lead ECG
Time frame: From enrollment up to 30 minutes
The absolute number of detected AF 30-second intervals by the CardioWatch's PPG algorithm will be determined and compared to the reference in-clinic 12-lead ECG, by means of calculating the positive predictive value (PPV), negative predictive value (NPV), specificity, and sensitivity. Performance goals for PPV and NPV are ≥90%, and performance goals for sensitivity and specificity are ≥95%.
Atrial fibrillation detection across 30-second intervals by CardioWatch single-lead ECG vs. 24-48 hour Holter
Time frame: From enrollment up to 48 hours
The absolute number of detected AF by the CardioWatch's single-lead ECG algorithm will be determined and compared to the reference ECG holter monitoring at the most similar moment in time by means of calculating the PPV, NPV, specificity, and sensitivity for timestamps corresponding to the single-lead spot checks.
Atrial fibrillation detection across 30-second intervals by CardioWatch single-lead ECG vs. short in-clinic 12-lead ECG
Time frame: From enrollment up to 30 minutes
The absolute number of detected AF by the CardioWatch's single-lead ECG algorithm will be determined and compared to the reference in-clinic ECG at the most similar moment in time by means of calculating the PPV, NPV, specificity, and sensitivity for timestamps corresponding to the single-lead spot checks.
11 secondary outcomes
Correspondence between cases with AF of greater than 6 minutes, 1 hour, 6 hours, and 12 hours
Time frame: From enrollment up to 48 hours
Compliance with ECG alerts
Time frame: From enrollment up to 48 hours
Amount of ECG attempts before successful ECG
Time frame: From enrollment up to 48 hours
Confirmation of AF by single-lead ECG
Time frame: From enrollment up to 48 hours
RMSE of HR measurement and reference
Time frame: From enrollment up to 48 hours
Atrial fibrillation detection performance for males vs. females
Time frame: Baseline information gathered during enrollment
Atrial fibrillation detection performance for BMI subgroups
Time frame: Baseline information gathered during enrollment
Atrial fibrillation detection performance for skin colour based subgroups
Time frame: Baseline information gathered during enrollment
Atrial fibrillation detection performance for ethinicity based subgroups
Time frame: Baseline information gathered during enrollment
Atrial fibrillation detection performance in light of patient activity
Time frame: From enrollment up to 48 hours
Atrial fibrillation detection performance in light of signal quality index
Time frame: From enrollment up to 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- 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.
Eelko Ronner, MD, PhD principal investigator
Reinier de Graaf Groep
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF) and Paroxysmal Atrial Fibrillation (PAF), run by Corsano Health B.V. at 1 site in Netherlands.
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 4 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: opening soon, as of the sponsor's last update on 2 May 2025. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eelko Ronner, MD, PhD (015-2603320 ext. +31, eronner@rdgg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial fibrillation detection across 30-second intervals by CardioWatch PPG algorithm vs. 24-48 hour Holter (time frame: From enrollment up to 48 hours). The study lists 4 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 2 May 2025.