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Trial record 1 of 4 for:    iBEAT
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iBeat Wristwatch Validation Study

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ClinicalTrials.gov Identifier: NCT03711695
Recruitment Status : Completed
First Posted : October 18, 2018
Last Update Posted : March 5, 2019
Sponsor:
Collaborator:
iBeat Inc.
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date February 27, 2018
First Posted Date October 18, 2018
Last Update Posted Date March 5, 2019
Actual Study Start Date March 22, 2018
Actual Primary Completion Date December 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 17, 2018)
  • Detect hemodynamic significant (e.g. Ventricular tachycardia, ventircular fibrillatio, supra ventricular tachycardia with fast ventricular rate, etc) arrhythmias using photoplethysmography [ Time Frame: Immediate ]
    Detect hemodynamic significant arrhythmia using changes in photoplethysmography [PPG] as measured using a wrist-watch.
  • Detect hemodynamic significant (e.g. Ventricular tachycardia, ventircular fibrillatio, supra ventricular tachycardia with fast ventricular rate, etc) arrhythmias using tissue oxygenation [ Time Frame: Immediate ]
    Detect hemodynamic significant arrhythmia using changes in tissue oxygenation as measured using a wrist-watch.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 17, 2018)
  • Detect benign arrhythmia (e.g. sinus tachycardia, atrial flutter, atrial fibrillation supra-ventricular tachycardia) using changes in photoplethysmography [ Time Frame: Immediate ]
    Detect hemodynamic significant arrhythmia by using changes in photoplethysmography signal, as measured using a wrist-watch.
  • Detect benign arrhythmia (e.g. sinus tachycardia, atrial flutter, atrial fibrillation supra-ventricular tachycardia) using changes in tissue oxygenation [ Time Frame: Immediate ]
    Detect hemodynamic significant arrhythmia by using changes in tissue oxygenation signal, as measured using a wrist-watch.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title iBeat Wristwatch Validation Study
Official Title Validation of Signal Waveforms in a Consumer-based Wristwatch Prototype Device During Standard Cardiac Procedures
Brief 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.
Detailed 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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The study population will consist of adults that present for either catheter ablation, cardiac device interrogation, or defibrillation threshold testing.
Condition Arrythmia, Cardiac
Intervention Device: iBeat wristwatch device
The participant will be asked to wear one iBeat wristwatch device on each arm during the planned procedure.
Study Groups/Cohorts
  • Group A
    Subjects presenting for catheter ablation for cardiac arrhythmias (e.g. atrial fibrillation, supraventricular tachycardia, or ventricular tachycardia)
    Intervention: Device: iBeat wristwatch device
  • Group B
    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).
    Intervention: Device: iBeat wristwatch device
  • Group C
    Subjects for clinically indicated defibrillation threshold testing (DFT) (with a transvenous or subcutaneous implantable cardioverter defibrillator (ICD) lead system)
    Intervention: Device: iBeat wristwatch device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 17, 2018)
55
Original Estimated Enrollment Same as current
Actual Study Completion Date December 30, 2018
Actual Primary Completion Date December 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03711695
Other Study ID Numbers 17-23761
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: The patient data will not be shared with other researchers. However, study outcomes will be published in peer-reviewed journals.
Responsible Party University of California, San Francisco
Study Sponsor University of California, San Francisco
Collaborators iBeat Inc.
Investigators
Principal Investigator: Jeffrey Olgin, MD University of California, San Francisco
Principal Investigator: Robert Avram, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date March 2019