PREdicting Atrial Fibrillation or Flutter (PREDATE-AF)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||PREdicting Determinants of Atrial Fibrillation or Flutter for Therapy Elucidation in Patients at Risk for Thromboembolic Events (PREDATE AF)"|
- Incidence of Atrial Fibrillation [ Time Frame: 2 years ] [ Designated as safety issue: No ]Incidence rate of AF calculated in each arm as the number of participants with an initial episode of AF lasting greater than or equal to six minutes divided by the total number of participants in that arm.
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
CHA2DS2-VASc Score 2 - 4
Physicians estimate the risk of stroke in AF patients using either the CHADS2 or CHA2DS2-VASc scoring; this is a low risk cohort.
CHA2DS2-VASc Score 5 - 6
Physicians estimate the risk of stroke in AF patients using either the CHADS2 or CHA2DS2-VASc scoring; this is a medium risk cohort.
CHA2DS2-VASc Score 7 - 9
Physicians estimate the risk of stroke in AF patients using either the CHADS2 or CHA2DS2-VASc scoring; this is a high risk cohort.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01851902
|United States, Mississippi|
|Keesler Medical Center|
|Keesler AFB, Mississippi, United States, 39534|