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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03711695
Other study ID # 17-23761
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 22, 2018
Est. completion date December 30, 2018

Study information

Verified date March 2019
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date December 30, 2018
Est. primary completion date December 30, 2018
Accepts healthy volunteers
Gender All
Age group 21 Years to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of California, San Francisco San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Francisco iBeat Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Immediate
Primary 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. Immediate
Secondary 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. Immediate
Secondary 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. Immediate
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