iBeat Wristwatch Validation Study

Arrythmia, Cardiac Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03711695
• Other study ID #: 17-23761
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• 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.

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