iBeat Wristwatch Validation Study

The goal of the proposed research is to validate PPG and TO signal waveforms recorded from a
wist-based sensor device, which is worn on one or both arms, during catheter ablation, device
interrogation, and defibrillation threshold testing (DFT). It is a non-invasive procedure
that will include placing a wrist-based sensor on subjects who consent participate. Data
collected from routine clinical care devices used during these procedures (catheter
ablations, device interrogations, and DFTs) will confirm data collected from the iBeat
wristwatch.

Inclusion Criteria:

1. Age ≥ 21 years and ≤ 85 years

2. Able to understand and give informed consent.

3. Subject is presenting for the following planned procedures:

3.1 Group A (25 subjects): Subjects presenting for catheter ablation for cardiac
arrhythmias (e.g. atrial fibrillation, supraventricular tachycardia, or ventricular
tachycardia) 3.2 Group B (25 subjects): Subjects judged based on the clinical evaluation of
high, greater than 75%, atrial pacing or ventricular pacing burden or known pacing
dependence with planned device interrogation for: 1) pacemaker (single or dual chamber), 2)
implantable cardioverter-defibrillator (single or dual chamber), or 3) cardiac
resynchronization therapy with or without defibrillator (single or dual chamber plus left
ventricular pacing).

3.3 Group C (5 subjects): Subjects for clinically indicated defibrillation threshold
testing (DFT) (with a transvenous or subcutaneous ICD lead system)

Exclusion Criteria:

1. Age < 21 years and > 85 years

2. Unable to or refuse to give written informed consent

3. Unwilling or unable to wear the smartwatch device on at least one wrist

4. Uncorrected severe aortic stenosis or subaortic stenosis (including hypertrophic
cardiomyopathy) with outflow tract obstruction > 50 mm

5. New York Heart Association Class IV Heart Failure