iBeat Wristwatch Validation Study

University of California San Francisco (UCSF)

Status: Completed

Conditions: Arrythmia, Cardiac

Treatments: Device: iBeat wristwatch device

Study type: Observational

Funder types: Other

Identifiers

NCT03711695

17-23761

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 55 patients

Sex: All

Ages: 21 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

55 participants in 3 patient groups

Group A

Description:

Subjects presenting for catheter ablation for cardiac arrhythmias (e.g. atrial fibrillation, supraventricular tachycardia, or ventricular tachycardia)

Treatment:

Device: iBeat wristwatch device

Group B

Description:

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).

Treatment:

Device: iBeat wristwatch device

Group C

Description:

Subjects for clinically indicated defibrillation threshold testing (DFT) (with a transvenous or subcutaneous implantable cardioverter defibrillator (ICD) lead system)

Treatment:

Device: iBeat wristwatch device