Clinical trial NCT06955273: Multi-Centre Based Study Recognition of Atrial Fibrillation With the Corsano CardioWatch 287-2 System
Official title: Multi-Centre Based Study Recognition of Atrial Fibrillation With the Corsano CardioWatch 287-2 System
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Atrial Fibrillation (AF)
Paroxysmal Atrial Fibrillation (PAF)
Keywords: wristband
wearable
atrial fibrillation
holter
ecg
remote monitoring
validation
Lead sponsor: Corsano Health B.V.
Sponsor class: INDUSTRY
First posted: 2025-05-02
Enrollment: 350
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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)

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;

Primary outcomes:
measure: Atrial fibrillation detection across 30-second intervals by CardioWatch PPG algorithm vs. 24-48 hour Holter
timeFrame: From enrollment up to 48 hours
measure: Atrial fibrillation detection across 30-second intervals by CardioWatch PPG algorithm vs. short in-clinic 12-lead ECG
timeFrame: From enrollment up to 30 minutes
measure: Atrial fibrillation detection across 30-second intervals by CardioWatch single-lead ECG vs. 24-48 hour Holter
timeFrame: From enrollment up to 48 hours
measure: Atrial fibrillation detection across 30-second intervals by CardioWatch single-lead ECG vs. short in-clinic 12-lead ECG
timeFrame: From enrollment up to 30 minutes
Secondary outcomes:
measure: Correspondence between cases with AF of greater than 6 minutes, 1 hour, 6 hours, and 12 hours
timeFrame: From enrollment up to 48 hours
measure: Compliance with ECG alerts
timeFrame: From enrollment up to 48 hours
measure: Amount of ECG attempts before successful ECG
timeFrame: From enrollment up to 48 hours
measure: Confirmation of AF by single-lead ECG
timeFrame: From enrollment up to 48 hours
measure: RMSE of HR measurement and reference
timeFrame: From enrollment up to 48 hours
measure: Atrial fibrillation detection performance for males vs. females
timeFrame: Baseline information gathered during enrollment
measure: Atrial fibrillation detection performance for BMI subgroups
timeFrame: Baseline information gathered during enrollment
measure: Atrial fibrillation detection performance for skin colour based subgroups
timeFrame: Baseline information gathered during enrollment
measure: Atrial fibrillation detection performance for ethinicity based subgroups
timeFrame: Baseline information gathered during enrollment
measure: Atrial fibrillation detection performance in light of patient activity
timeFrame: From enrollment up to 48 hours
measure: Atrial fibrillation detection performance in light of signal quality index
timeFrame: From enrollment up to 48 hours
Other outcomes:
Locations:
city: Delft
country: Netherlands
facility: Reinier de Graaf Gasthuis
state: Zuid Holland
Study officials:
affiliation: Reinier de Graaf Groep
name: Eelko Ronner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: