PREdicting Atrial Fibrillation or Flutter — PREDATE-AF  

Atrial Fibrillation Clinical Trial

Official title: PREdicting Determinants of Atrial Fibrillation or Flutter for Therapy Elucidation in Patients at Risk for Thromboembolic Events (PREDATE AF)"

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to determine, through continuous monitoring with a cardiac monitoring device placed under the skin, the incidence of atrial fibrillation or flutter (AF). The cardiac monitor will be placed in patients without symptoms but at risk for AF. It is hoped that this information may assist health care professionals in treatment decisions related to the early identification of patients at high risk for AF.

Clinical Trial Description

Background: Atrial fibrillation and atrial flutter (AF) are common cardiac arrhythmias that confer a substantial stroke burden largely because the vast majority of AF is asymptomatic and identified after a stroke has occurred. Until recently, only intermittent cardiac monitors were available, with most AF episodes remaining undetected due to poor sensitivity. Health care providers estimate the risk of stroke in AF patients using a patient's comorbidity profile to determine who should be treated with oral anticoagulant therapy for stroke prevention. The incidence of AF in patients with high stroke risk comorbidities is not known. The Medtronic Reveal insertable cardiac monitor (ICM) is a continuous monitoring device with excellent AF detection.

Purpose and Study Objectives: The purpose of the PREDATE AF study is to determine the incidence of AF in asymptomatic patients at high risk for having AF in order to determine which patient characteristics are most predictive of the development of AF. The primary objective is to determine the AF incidence rate; secondary objectives include identifying the most important predictors of AF onset and identifying how physicians respond once AF has been discovered.

Study Design: The trial is a prospective, single arm, open-label, single center clinical study which will enroll up to 360 patients at high risk of having AF based upon their comorbidity profile, who will then receive an ICM. Enrolled subjects will be followed for a minimum of 18 months to monitor for the detection of AF. Monthly ICM data transmissions will be the mechanism of AF detection, and this information will be utilized to determine the AF incidence rate ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter

• NCT number: NCT01851902
• Study type: Observational
• Source: Keesler Air Force Base Medical Center
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2013
• Completion date: June 2016