iBeat Wristwatch Validation Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-22

Study Completion Date

2018-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Arrythmia, Cardiac

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

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

iBeat wristwatch device

Intervention Type 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).

iBeat wristwatch device

Intervention Type 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)

iBeat wristwatch device

Intervention Type DEVICE

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

Interventions

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iBeat wristwatch device

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No