Summary

for people ages 21-85 (full criteria)
at San Francisco, California
study started
estimated completion:
Jeffrey Olgin Robert Avram

Description

Summary

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.

Official Title

Validation of Signal Waveforms in a Consumer-based Wristwatch Prototype Device During Standard Cardiac Procedures

Details

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.

Keywords

Arrythmia, Cardiac ibeat wrist watch digital health Arrythmia Arrhythmias, Cardiac iBeat wristwatch device

Eligibility

You can join if…

Open to people ages 21-85

  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)

You CAN'T join if...

  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

Location

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03711695
Lead Scientists
Jeffrey Olgin
Robert Avram
Study Type
Observational
Last Updated