NCT03711695

iBeat Wristwatch Validation Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 55 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: —

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.

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.

Conditions

• Arrythmia, Cardiac

Interventions

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

Timeline

• Start date: 2018-03-22
• Primary completion: 2018-12-30
• Completion: 2018-12-30
• First posted: 2018-10-18
• Last updated: 2019-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study