iBeat Wristwatch Validation Study

NCT03711695 | Completed FDA Device

• 1 other identifier: 17-23761
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Arrythmia, Cardiac

Keywords

ibeat; wrist watch; digital health; Arrythmia

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Detect benign arrhythmia (e.g. sinus tachycardia, atrial flutter, atrial fibrillation supra-ventricular tachycardia) using changes in photoplethysmography

  Immediate

• Detect benign arrhythmia (e.g. sinus tachycardia, atrial flutter, atrial fibrillation supra-ventricular tachycardia) using changes in tissue oxygenation

  Immediate

Study Arms (3)

Group A

Subjects presenting for catheter ablation for cardiac arrhythmias (e.g. atrial fibrillation, supraventricular tachycardia, or ventricular tachycardia)

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).

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)

Device: iBeat wristwatch device

Interventions

iBeat wristwatch device DEVICE

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

Group A; Group B; Group C

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥ 21 years and ≤ 85 years
• Able to understand and give informed consent.
• Subject is presenting for the following planned procedures:
• 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).
• Group C (5 subjects): Subjects for clinically indicated defibrillation threshold testing (DFT) (with a transvenous or subcutaneous ICD lead system)

You may not qualify if:

• Age \< 21 years and \> 85 years
• Unable to or refuse to give written informed consent
• Unwilling or unable to wear the smartwatch device on at least one wrist
• Uncorrected severe aortic stenosis or subaortic stenosis (including hypertrophic cardiomyopathy) with outflow tract obstruction \> 50 mm
• New York Heart Association Class IV Heart Failure

Sponsors & Collaborators

• University of California, San Francisco: lead
• iBeat Inc.: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffrey Olgin, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Robert Avram, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: October 18, 2018
• Study Start: March 22, 2018
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: March 5, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)