NCT03761394

Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke

Smartwatch Monitoring for Atrial Fibrillation After Stroke

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: University of Massachusetts, Worcester · Academic / Other
• Sex: All
• Age: 50 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The goal of this research study is to develop a smartphone application capable of monitoring paroxysmal atrial fibrillation (pAF) in people who have survived a stroke or transient ischemic attack (TIA) or people who are at risk for a stroke and are age 50 and older. The study team plans to develop a highly effective and easy to use cardiovascular surveillance system to monitor patients for pAF on a nearly continuous basis. People involved in the development of this system include patients, their caregivers, health care providers, and computer programmers.

Conditions

• Stroke
• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Testing Devices	Pulsewatch system testing application on smartphone with smartwatch.
DEVICE	Cardea Solo by Cardiac Insight	Gold-standard cardiac monitor for comparison of testing devices.
DEVICE	Kardia Mobile by AliveCor	Mobile ECG device for comparison of testing devices during the extended use period.

Timeline

• Start date: 2019-09-03
• Primary completion: 2021-09-20
• Completion: 2021-09-20
• First posted: 2018-12-03
• Last updated: 2023-11-18
• Results posted: 2023-11-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study