iBeat Wristwatch Validation Study
Completed
Conditions studied: Arrythmia, Cardiac
In brief
The iBeat Study is a single-center, prospective, unblinded validation of the photoplethysmography (PPG) and tissue oximetry (TO) signal waveforms recorded from a wrist-based sensor devices.
Key facts
- Study ID
- NCT03711695
- Run by
- University of California, San Francisco
- People needed
- 55
- Starts
- 2018-03-22
- Expected to finish
- 2018-12-30
- Last updated by the study team
- 2019-03-05
Who can join
Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 21 years and ≤ 85 years
- Able to understand and give informed consent.
- Subject is presenting for the following planned procedures:
- 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 Group C (5 subjects): Subjects for clinically indicated defibrillation threshold testing (DFT) (with a transvenous or subcutaneous ICD lead system)
You may not qualify if…
- Age < 21 years and > 85 years
- Unable to or refuse to give written informed consent
- Unwilling or unable to wear the smartwatch device on at least one wrist
- Uncorrected severe aortic stenosis or subaortic stenosis (including hypertrophic cardiomyopathy) with outflow tract obstruction > 50 mm
- New York Heart Association Class IV Heart Failure
Where it is running
- University of California, San Francisco — San Francisco, California, United States
Full record on ClinicalTrials.gov
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