REVEAL AF: Incidence of AF in High Risk Patients

NCT01727297 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 446

Last updated 2018-04-30

Study results available
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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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01727297 on ClinicalTrials.gov