Status:
NOT_YET_RECRUITING
The Effectiveness of Patch-Based Screening for Pre-Symptomatic Atrial Fibrillation to Improve Patient Outcome
Lead Sponsor:
VA Office of Research and Development
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
* The goal of the screening trial is to determine whether early screening for atrial fibrillation improves outcomes, including lowering the chance of death, hospitalization for stroke, blood clots, he...
Detailed Description
The study hypothesis is that screening for atrial fibrillation (AF) in participants at risk for AF will be associated with a reduction in adverse cardiovascular outcomes. This trial will enroll 24,060...
Eligibility Criteria
Inclusion
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Male or female, age \>=65 years
- CHA2DS2-Vasc score \>=3. The score is comprised of age (2 points for 75, 1 point for 65-74), sex (1 point for female), history of stroke, TIA, or systemic embolism (2 points), and history of heart failure, hypertension, vascular disease (including MI, peripheral artery disease, or aortic plaque), or diabetes (1 point each).
Exclusion
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Current use of anticoagulation
- Diagnosis of AF (from administrative records or per patient during consent)
- Cardio-thoracic surgery in the prior 3 months
- Presence of pacemaker, implantable defibrillator, or implanted cardiac monitor
- Clinically significant allergy to adhesives, as reported by the patient during screening for trial enrollment
- Planned use of a brain or spinal-cord stimulator, TENS unit, or MRI scan during the period when the Zio Patch will be worn
Key Trial Info
Start Date :
June 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 3 2033
Estimated Enrollment :
24060 Patients enrolled
Trial Details
Trial ID
NCT06953778
Start Date
June 1 2026
End Date
October 3 2033
Last Update
May 1 2025
Active Locations (1)
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1
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1207