Evaluation of the Detection of Atrial Fibrillation by a Wearable Dynamic ECG Recorder

Evaluation of the Consistency Between the Detection of Atrial Fibrillation by a Wearable Dynamic ECG Recorder and a Control Instrument

A Randomized, Crossover Trial is conducted to Evaluate Consistency Atrial fibrillation diagnosis between the Wearable Dynamic ECG Recorder and the Control device.

In this investigation, the following indicators is also evaluated:

1. Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation compared with physician-adjudicated Gold Standard ECG recorder.
2. Waveform qualitative assessment
3. Safety incident assessments. 114 subjects (60 healthy subjects in phase I and 54 subjects with atrial fibrillation diagnosis in phase II) are enrolled in the investigation according to the criteria.

Inclusion Criteria:

• - All study participants must be able to provide written informed consent prior to study procedure. This study has 2 Phases.

Phase 1:

• Health conscious individuals
• > 18 years of age

Phase 2:

• > 18 years of age
• non critical patients ever diagnosed with atrial fibrillation

Exclusion Criteria:

• • < 18 years old

  • Unable to consent

Phase 1:

• > 80 years of age
• Previous history of cardiac disease (e.g., atrial fibrillation, myocardial infarction, congestive heart failure)
• current status of non-sinus heart rhythm

Phase 2:

- Critical patients