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Diagnostic Test

Atrial Fibrillation Spot-Check for Atrial Fibrillation (VITAL-AF Trial)

N/A
Waitlist Available
Led By Steven Lubitz, MD, MPH
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-months following initial prescription of anticoagulation (ie, up to 24 months after study start)
Awards & highlights

VITAL-AF Trial Summary

The overall goal of this study is to assess the effectiveness of screening for undiagnosed atrial fibrillation (AF) using simple, efficient, and portable electronic health and mobile technologies in a healthcare system. The investigators propose to perform population-based screening for undiagnosed AF as part of usual care in patients ≥ 65 years when their vital signs are checked (spot-check) at scheduled outpatient visits in adult Massachusetts General Hospital (MGH) primary care clinics. Patients will receive routine care by their primary care provider (PCP) based upon the results of the screening during the visit. The investigators hypothesize that rates of AF detection among individuals ≥ 65 years in the MGH primary care network will be greater among patients in clinics assigned to the spot-check arm compared to patients in clinics assigned to the usual care arm of the study.

VITAL-AF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-months following initial prescription of anticoagulation (ie, up to 24 months after study start)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-months following initial prescription of anticoagulation (ie, up to 24 months after study start) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incident AF during the study period
Secondary outcome measures
Continued prescription of anticoagulation at 12 months among those started on anticoagulation during the study period
Incident AF associated with a primary care encounter during the study period
Major hemorrhage within 24-months of the study start
+2 more

VITAL-AF Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Atrial Fibrillation Spot-CheckExperimental Treatment1 Intervention
For eligible patients from primary care clinics randomly selected for the Atrial Fibrillation Spot-Check arm, practice medical assistants will screen assenting patients for undiagnosed AF during regularly scheduled office visits using a single-lead handheld electrocardiogram (ECG). Single-lead handheld electrocardiogram readings detecting AF will be confirmed during the same office visit with a standard 12-lead ECG at the discretion of the primary care physician. If AF is detected, the patient's PCP will be able to address the condition with them during the clinic visit and initiate appropriate follow-up to manage the AF.
Group II: Usual CareActive Control1 Intervention
For eligible patients from primary care clinics randomly selected for the Usual Care arm, they will receive standard care during outpatient visits without change.

Find a Location

Who is running the clinical trial?

University of Massachusetts, WorcesterOTHER
343 Previous Clinical Trials
951,302 Total Patients Enrolled
7 Trials studying Atrial Fibrillation
3,633 Patients Enrolled for Atrial Fibrillation
Massachusetts General HospitalLead Sponsor
2,930 Previous Clinical Trials
13,163,037 Total Patients Enrolled
15 Trials studying Atrial Fibrillation
30,375 Patients Enrolled for Atrial Fibrillation
Steven Lubitz, MD, MPHPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
450,000 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
450,000 Patients Enrolled for Atrial Fibrillation

Frequently Asked Questions

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Recent research and studies
clinicaltrials.govStudy
Screening for Atrial Fibrillation Among Older Patients in Primary Care Clinics
Steven A Lubitz 2018. "Screening for Atrial Fibrillation Among Older Patients in Primary Care Clinics". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03515057.
~5296 spots leftby Apr 2025
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