Purpose

The purpose of this study is to determine if an AF detection intervention in men and women at least 70 years of age with undiagnosed atrial fibrillation (AF) or atrial flutter (AFL) reduces the person-years incidence rate of stroke compared to usual care (no AF detection intervention).

Conditions

Eligibility

Eligible Ages
Over 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Men and women at least 70 years of age who are new or established participants in the primary care practice - Willing to provide consent to participate in the study and to use personal health information to ascertain endpoints from the Center for Medicare & Medicaid Services (CMS) Medicare Claims Database and to access data from health records - Health insurance by Medicare Parts A & B (Medicare Fee-for-service)

Exclusion Criteria

  • Oral anticoagulation (OAC) for any indication at the time of enrollment - History of Atrial Fibrillation (AF) or Atrial Flutter (AFL) as documented in the participant's current medical problem list - Any condition the investigator considers a contraindication to OAC, e.g., bleeding that required medical attention or severe renal impairment - Any condition the investigator considers will prevent compliance with study instructions - Implanted cardiac devices (pacemakers, implantable cardiac defibrillators, or cardiac resynchronization therapy, and implantable loop recorders) - History of allergy to adhesive Other protocol-defined inclusion/exclusion criteria could apply

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Zio®XT Monitor Arm
  • Other: Zio®XT Monitor
    A Zio® XT monitor will be affixed to the participant's chest
No Intervention
Usual Care Arm

Recruiting Locations

Vanderbilt University
Nashville, Tennessee 37212
Contact:
Harvey Murff, Site 0309

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
please email:
Clinical.Trials@bms.com

Detailed Description

This a prospective, randomized study in primary care practices.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.