A Study to Determine if Identification of Undiagnosed Atrial Fibrillation in People at Least 70 Years of Age Reduces the Risk of Stroke (GUARD-AF)
Status and phase
Completed
Phase 4
Conditions
Atrial Flutter
Atrial Fibrillation
Treatments
Other: Zio®XT Monitor
Details and patient eligibility
About
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).
Full description
This a prospective, randomized study in primary care practices.
Enrollment
11,931 patients
Sex
All
Ages
70+ years old
Volunteers
No Healthy Volunteers
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
- Not able to wear the Zio®XT monitor or not able to apply the monitor by herself/himself or with the help of a caregiver
Other protocol-defined inclusion/exclusion criteria could apply
Trial design
Primary purpose
Prevention
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
11,931 participants in 2 patient groups
Zio®XT Monitor Arm
Other group
Treatment:
Other: Zio®XT Monitor
Usual Care Arm
No Intervention group
Trial contacts and locations
176
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Data sourced from clinicaltrials.gov
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