REVEAL AF: Incidence of AF in High Risk Patients
NCT01727297 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 446
Last updated 2018-04-30
Summary
This study is to determine, through continuous monitoring with the Reveal implantable cardiac monitor (ICM), the incidence of atrial fibrillation (AF) in patients suspected to be at high risk for having AF and to understand how physicians manage these patients after AF has been detected. This study will also seek to identify what patient characteristics are most predictive of developing AF.
Conditions
Interventions
- DEVICE
-
REVEAL Implantable Cardiac Monitor
Sponsors & Collaborators
-
Medtronic Cardiac Rhythm and Heart Failure
lead INDUSTRY
Principal Investigators
-
James A Reiffel, MD · Columbia University
Study Design
- Allocation
- NA
- Purpose
- SCREENING
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-11-13
- Primary Completion
- 2017-01-13
- Completion
- 2017-01-30
- FDA Device
- Yes
Countries
- United States
- Austria
- Germany
- Italy
- Netherlands
- Slovenia
- Spain
Study Locations
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