Clinical trial NCT05167058: Electrocardiographic Diagnostic Performance of the Apple Watch Augmented With an Artificial Intelligence Algorithm
Official title: Confirmatory Clinical Investigation of Electrocardiographic Diagnostic Performance of the Apple Watch Augmented With an Artificial Intelligence Algorithm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Tachycardia
Bradycardia
Premature Supraventricular Beat
Premature Ventricular Contraction
Lead sponsor: Cardiologs Technologies
Sponsor class: INDUSTRY
First posted: 2021-12-22
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 subjects: subjects who are hospitalized for cardioversion or AF ablation procedure per standard of care

Brief summary: The SWAF study will compare the performance of a smartwatch combined with Cardiologs Platform algorithm in the detection of Atrial Fibrillation and other arrhythmias with that measured on a manually read 12-lead ECG in subjects hospitalized for cardioversion or AF ablation.

Detailed description: The SWAF study is a prospective, non-significant risk, non-randomized, multicentric, open, comparative, confirmatory study.

Under subject consent, subjects hospitalized for cardioversion or AF ablation will have a smartwatch ECG recording done simultaneously with 12-lead ECG measurement right before the intervention. If a subject is found in Normal Sinus Rhythm he/she will be discharged otherwise the patient will undergo cardioversion and will have simultaneous recordings done a second time after the intervention. All the measurements will be done in accordance with the existing subject monitoring protocol.

Eligibility criteria: Inclusion Criteria:

* Subjects over 18, able and willing to participate in the study
* Subjects who are admitted to the hospital for a cardioversion or AF ablation procedure.
* Subjects having read the patient information letter and provided his/her consent to participate in writing, by dating and signing the informed consent prior to any trial-related procedure being conducted

Exclusion Criteria:

* Subjects with paced rhythm or implanted electronic devices
* Pregnant or breast-feeding subjects

Primary outcomes:
measure: Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting AF (Atrial Fibrillation or Flutter) as identified by the physician on the 12-lead ECG
timeFrame: Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital
Secondary outcomes:
measure: Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting AF as identified by the physician on the smartwatch ECG
timeFrame: Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital
measure: Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting Sinus Rhythm as identified by the physician on the smartwatch ECG
timeFrame: Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital
measure: Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting Tachycardia as identified by the physician on the smartwatch ECG
timeFrame: Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital
measure: Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting Bradycardia as identified by the physician on the smartwatch ECG
timeFrame: Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital
measure: Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting Premature Supraventricular Complexes as identified by the physician on the smartwatch ECG
timeFrame: Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital
measure: Evaluation of the performance of smartwatch ECG interpreted by Cardiologs Artificial Intelligence in detecting Premature Ventricular Complexes as identified by the physician on the smartwatch ECG
timeFrame: Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital
measure: Assessment of the proportion of smartwatch ECGs identified as inconclusive by Cardiologs Artificial Intelligence and by the physician
timeFrame: Readings taken simultaneously right before and right after the cardioversion according to the monitoring protocol at the hospital
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack Meridian School of Medicine
state: New Jersey
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center/ NewYork Presbyterian Hospital
state: New York
Study officials:
affiliation: Columbia University, New York
name: Elaine Y Wan, MD
role: PRINCIPAL_INVESTIGATOR
References: