Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke

Completed · Not applicable

Conditions studied: Stroke, Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT03761394

Run by

University of Massachusetts, Worcester

People needed

120

Starts

2019-09-03

Expected to finish

2021-09-20

Last updated by the study team

2023-11-18

Who can join

Age: 50 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• History of Transient Ischemic Attack (TIA) or stroke or at risk for stroke based on a CHA2DS2-VASc score equal to or greater to a score of 3, presenting at the UMass Memorial Medical Center (UMMMC) inpatient service or ambulatory clinic (neurology clinics and cardiovascular clinics included)
• Age: greater to or equal to 50 years of age
• Able to sign informed consent
• Willing to participant in a focus groups and/or Hack-a-thon for Aim 1 participants only
• Willing and capable of using Pulsewatch (smartwatch and smartphone app) daily for up to 44-days and returning to UMMMC for up to two study visits for Aims 2 and 3 participants only

You may not qualify if…

• Major contraindication to anti-coagulation treatment
• Plans to move our of the area over the 44-day follow up period
• Serious physical illness (e.g., unable to interact with a smart device, or communicate verbally or via written text) that would interfere with study participation
• Known allergies or hypersensitivities to medical grade hydrocolloid adhesives or hydrogel
• Patient with life threatening arrhythmia's who require in-patient monitoring for immediate analysis
• Patient with implantable pacemaker as paced beats interfere with ECG readings
• Lacking capacity to sign informed consent
• Unable to read and write in English
• Plans to move from the area during the study period
• Unwilling to complete all study procedures
• Major contraindication to anti-coagulation treatment (i.e., major hemorrhagic stroke)
• Individuals who are not yet adults
• Pregnant women
• Prisoners

Where it is running

• UMass Chan Medical School — Worcester, Massachusetts, United States

Full record on ClinicalTrials.gov

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