PREdicting Atrial Fibrillation or Flutter

NCT01851902 | Unknown

• 1 other identifier: FKE20130012H
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation; Atrial Flutter

Keywords

Atrial Fibrillation; Atrial Flutter; Arrhythmia

Outcome Measures

Primary Outcomes (1)

• Incidence of Atrial Fibrillation

  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.

  2 years

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The PREDATE AF trial is a prospective, single arm, open-label, single center clinical study to evaluate the incidence of AF in patients that are suspected to be at high risk of having AF, as defined by a modified CHA2DS2-VASc score.

You may qualify if:

• Patient meets the approved FDA indication to receive the ICM
• Patient is suspected, based on demographics, to be at high risk of having AF, as determined by the clinical investigator
• Patient has a CHA2DS2-VASc score ≥ 2 \[Note: stroke/TIA criterion as part of the CHA2DS2-VASc score for this trial is limited to either an ischemic stroke or TIA, which occurred more than one year prior to enrollment.\]
• Patient is 18 years of age or older
• Patient has a life expectancy of 18 months or more

You may not qualify if:

• Patient has a documented history of AF or atrial flutter
• Patient has a symptom complex consistent with an arrhythmia (where an ICM may have an alternate indication for use)
• Patient had an ischemic stroke or TIA within past year prior to enrollment
• Patient has a history of a hemorrhagic stroke
• Patient is currently implanted with a permanent pacemaker, insertable loop recorder, implantable defibrillator, cardiac resynchronization therapy device (pacemaker or defibrillator)
• NYHA Class IV Heart Failure patient
• Patient had heart surgery within previous 90 days prior to enrollment
• Patient had an MI within the previous 90 days prior to enrollment
• Patient is taking chronic immunosuppressant therapy
• Patient is taking an anti-arrhythmic drug
• Patient is contraindicated for long term anticoagulation medication
• Patient is taking a long-term anticoagulation medication
• Any concomitant condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse, emotional / psychological diagnosis)
• Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from the principal investigator
• Patient has a creatinine clearance \<30 ml/min or is on dialysis

Sponsors & Collaborators

• Keesler Air Force Base Medical Center: lead

Study Sites (1)

Keesler Medical Center

Keesler Air Force Base, Mississippi, 39534, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Javed M Nasir, MD

  Keesler Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2013
• First Posted: May 13, 2013
• Study Start: May 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 5, 2016

Record last verified: 2016-01

Locations

US (1)