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

NCT06955273 | Not Yet Recruiting FDA Device

• 1 other identifier: COR-AF
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

wristband; wearable; atrial fibrillation; holter; ecg; remote monitoring; validation

Outcome Measures

Primary Outcomes (4)

• 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%.

  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%.

  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.

  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.

  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

  From enrollment up to 48 hours

• Compliance with ECG alerts

  From enrollment up to 48 hours

• Amount of ECG attempts before successful ECG

  From enrollment up to 48 hours

• Confirmation of AF by single-lead ECG

  From enrollment up to 48 hours

• RMSE of HR measurement and reference

  From enrollment up to 48 hours

Study Arms (4)

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.

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%).

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

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.

Device: Corsano CardioWatch 287-2

Interventions

Corsano CardioWatch 287-2 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 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.

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Corsano Health B.V.: lead

Study Sites (1)

Reinier de Graaf Gasthuis

Delft, South Holland, 2625AD, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eelko Ronner, MD, PhD

  Reinier de Graaf Groep

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eelko Ronner, MD, PhD

CONTACT

015-2603320; eronner@rdgg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: May 2, 2025
• Study Start: May 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)