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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

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.

Condition or disease Intervention/treatment
Arrythmia, Cardiac Device: iBeat wristwatch device

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.

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Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Validation of Signal Waveforms in a Consumer-based Wristwatch Prototype Device During Standard Cardiac Procedures
Actual Study Start Date : March 22, 2018
Actual Primary Completion Date : December 30, 2018
Actual Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

Group/Cohort Intervention/treatment
Group A
Subjects presenting for catheter ablation for cardiac arrhythmias (e.g. atrial fibrillation, supraventricular tachycardia, or ventricular tachycardia)
Device: iBeat wristwatch device
The participant will be asked to wear one iBeat wristwatch device on each arm during the planned procedure.

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

Group C
Subjects for clinically indicated defibrillation threshold testing (DFT) (with a transvenous or subcutaneous implantable cardioverter defibrillator (ICD) lead system)
Device: iBeat wristwatch device
The participant will be asked to wear one iBeat wristwatch device on each arm during the planned procedure.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03711695


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
iBeat Inc.
Investigators
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Principal Investigator: Jeffrey Olgin, MD University of California, San Francisco
Principal Investigator: Robert Avram, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03711695    
Other Study ID Numbers: 17-23761
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (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.

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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
Keywords provided by University of California, San Francisco:
ibeat
wrist watch
digital health
Arrythmia
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes