Status:
COMPLETED
Engaging Patients to Help Achieve Increased Patient Choice and Engagement for AFib Stroke Prevention
Lead Sponsor:
Stanford University
Collaborating Sponsors:
American Heart Association
East Carolina University
Conditions:
Atrial Fibrillation
Atrial Flutter
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A multi-center, randomized controlled 2-arm trial comparing the effectiveness of an innovative shared decision-making pathway and usual care for Atrial Fibrillation Stroke Prevention
Detailed Description
This study will test to see if a new type of decision-making process tool, called a Shared Decision Making Pathway, can make a difference in decreasing the risk of stroke due to a condition called Atr...
Eligibility Criteria
Inclusion
- ≥ 18 y/o
- Non-valvular atrial fibrillation or atrial flutter (AFib)
- CHA2DS2-VASc stroke score of:
- Men: 1 or more
- Women: 2 or more
- Able to consent in English or Spanish (if resources allow) and follow study instructions
Exclusion
- Moderate to severe mitral stenosis
- Mechanical valve replacement
- Absolute contraindication to anticoagulation (Based on clinician judgment)
- Indication for anticoagulation therapy for a condition other than atrial fibrillation
- Left atrial appendage exclusion (by surgery or device placement)
- At the clinical discretion of the investigator
Key Trial Info
Start Date :
December 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 17 2022
Estimated Enrollment :
1001 Patients enrolled
Trial Details
Trial ID
NCT04096781
Start Date
December 18 2019
End Date
August 17 2022
Last Update
April 5 2024
Active Locations (5)
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1
Stanford University
Palo Alto, California, United States, 94305
2
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121
3
Cooper University Hospital
Camden, New Jersey, United States, 08103
4
East Carolina University
Greenville, North Carolina, United States, 27858