iBeat Wristwatch Validation Study

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

Study Description

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.

Study Design

• 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

Groups and Cohorts

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.

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Principal Investigator: Jeffrey Olgin, MD; University of California, San Francisco
• Principal Investigator: Robert Avram, MD; University of California, San Francisco

More Information

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT03711695
• Other Study ID Numbers: 17-23761
• First Posted: October 18, 2018
• 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.

• 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:

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes