Multi-Centre Based Study Recognition of Atrial Fibrillation With the Corsano CardioWatch 287-2 System

NCT ID: NCT06955273

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-01-31

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.

Conditions

Atrial Fibrillation (AF); Paroxysmal Atrial Fibrillation (PAF)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Corsano CardioWatch 287-2

Intervention Type: DEVICE

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.

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%).

Corsano CardioWatch 287-2

Intervention Type: DEVICE

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.

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

Corsano CardioWatch 287-2

Intervention Type: DEVICE

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.

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.

Corsano CardioWatch 287-2

Intervention Type: DEVICE

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.

Interventions

Corsano CardioWatch 287-2

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.

Intervention Type: DEVICE

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;

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Corsano Health B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eelko Ronner, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Reinier de Graaf Groep

Locations

Reinier de Graaf Gasthuis

Delft, South Holland, Netherlands

Countries

Netherlands

Central Contacts

Eelko Ronner, MD, PhD

Role: CONTACT

eronner@rdgg.nl

015-2603320 ext. +31

Facility Contacts

Eelko Ronner, MD, PhD

Role: primary

eronner@rdgg.nl

015 - 260 33 20 ext. +31

Other Identifiers

COR-AF

Identifier Type: -

Identifier Source: org_study_id