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Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke

NCT03761394 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-11-18

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • University of Connecticut

    collaborator OTHER

  • Northeastern University

    collaborator OTHER

  • Brigham and Women's Hospital

    collaborator OTHER

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • University of Massachusetts, Worcester

    lead OTHER

Principal Investigators

  • Timothy Fitzgibbons, MD, PhD · UMass Medical School

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-03
Primary Completion
2021-09-20
Completion
2021-09-20
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03761394 on ClinicalTrials.gov