iBeat Wristwatch Validation Study

University of California, San Francisco55 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Arrythmia, Cardiac

Interventions

iBeat wristwatch deviceDEVICE

The participant will be asked to wear one iBeat wristwatch device on each arm during the planned procedure.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

University of California, San Francisco

San Francisco, California, United States

Outcomes

Primary Outcomes

Detect hemodynamic significant (e.g. Ventricular tachycardia, ventircular fibrillatio, supra ventricular tachycardia with fast ventricular rate, etc) arrhythmias using photoplethysmography

Detect hemodynamic significant arrhythmia using changes in photoplethysmography \[PPG\] as measured using a wrist-watch.

Time frame: Immediate

Detect hemodynamic significant (e.g. Ventricular tachycardia, ventircular fibrillatio, supra ventricular tachycardia with fast ventricular rate, etc) arrhythmias using tissue oxygenation

Detect hemodynamic significant arrhythmia using changes in tissue oxygenation as measured using a wrist-watch.

Time frame: Immediate

Secondary Outcomes

Detect benign arrhythmia (e.g. sinus tachycardia, atrial flutter, atrial fibrillation supra-ventricular tachycardia) using changes in photoplethysmography

Detect hemodynamic significant arrhythmia by using changes in photoplethysmography signal, as measured using a wrist-watch.

Time frame: Immediate

Detect benign arrhythmia (e.g. sinus tachycardia, atrial flutter, atrial fibrillation supra-ventricular tachycardia) using changes in tissue oxygenation

Detect hemodynamic significant arrhythmia by using changes in tissue oxygenation signal, as measured using a wrist-watch.

Time frame: Immediate

Data from ClinicalTrials.gov

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