Multi-Centre Based Study Recognition of Atrial Fibrillation With the Corsano CardioWatch 287-2 System
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorCorsano Health B.V.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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 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)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Corsano CardioWatch 287-2
DevicePatients 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.
Treatment groups
350 Participants
are divided into 4 treatment groupsGroup A: Group A: patients receiving 24-48 hour holter monitoring as standard of care1 intervention
Group B: Group B: patients diagnosed with (paroxysmal) AF presenting to the clinic for routine follow-up1 intervention
Group C: Group C: patients diagnosed with (paroxysmal) AF registered in a patient organisation1 intervention
Group D: Group D: patients receiving a 12-lead ECG at the outpatient clinic as standard of care.1 intervention
Trial outcomes
Primary outcomes
1
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%.
Time frame
From enrollment up to 48 hours2
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%.
Time frame
From enrollment up to 30 minutes3
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.
Time frame
From enrollment up to 48 hours4
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.
Time frame
From enrollment up to 30 minutesSecondary outcomes
1
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).
Time frame
From enrollment up to 48 hours2
Compliance with ECG alerts
Compliance with ECG alerts during at home holter-monitoring, together with:
Time frame
From enrollment up to 48 hours3
Amount of ECG attempts before successful ECG
Amount of ECG attempts before successful ECG during at home holter-monitoring
Time frame
From enrollment up to 48 hours4
Confirmation of AF by single-lead ECG
The confirmation of AF: single-lead ECG vs PPG-based (ECGs within one hour of alert)
Time frame
From enrollment up to 48 hoursSponsors and contacts
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Source ClinicalTrials.gov
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