REVEAL AF: Incidence of AF in High Risk Patients

Completed · Not applicable

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT01727297

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

446

Starts

2012-11-13

Expected to finish

2017-01-30

Last updated by the study team

2018-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient meets the approved indications to receive the Reveal ICM
• Patient is suspected, based on symptomatology and/or demographics, of having atrial fibrillation or at high risk of having AF, as determined by the clinical investigator
• Patient has a Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, prior Stroke or transient ischemic attack (TIA) or thromboembolism (doubled) (CHADS2) score ≥ 3 OR has a CHADS2 score = 2 with at least one of the following documented: renal impairment (GFR 30-60 ml/min), sleep apnea, coronary artery disease, or chronic obstructive pulmonary disease. Note: stroke/TIA criterion as part of the CHADS2 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
• Patient, or legally authorized representative, is willing to sign and date the consent form
• Patient is willing and able to be remotely monitored (i.e., eligible for enrollment into the Medtronic CareLink Network)

You may not qualify if…

• Patient has a documented history of AF or atrial flutter
• 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 an implantable pulse generator (IPG), implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy pacemaker (CRT-P), or cardiac resynchronization therapy defibrillator (CRT-D) device
• New York Heart Association (NYHA) Class IV Heart Failure patient
• Patient had heart surgery within previous 90 days prior to enrollment
• Patient had a myocardial infarction (MI) within the previous 90 days prior to enrollment
• Patient is taking chronic immuno-suppressant 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 Medtronic study manager
• Patient has a creatinine clearance <30 ml/min or is on dialysis

Where it is running

• Cardiovascular Consultants Heart Center — Fresno, California, United States
• Desert Heart Rhythm Consultants — Palm Springs, California, United States
• Healdsburg Cardiology — Windsor, California, United States
• Nanticoke Cardiology — Seaford, Delaware, United States
• Bradenton Cardiology — Bradenton, Florida, United States
• The Cardiac & Vascular Institute — Gainesville, Florida, United States
• Cardiac Clinic — Kissimmee, Florida, United States
• Northside Hospital — St. Petersburg, Florida, United States
• North Georgia Heart Foundation — Gainesville, Georgia, United States
• Premier HealthCare — Bloomington, Indiana, United States
• Cardiovascular Consultants PC (Munster IN) — Munster, Indiana, United States
• The University Kansas Medical Center Research Institute Inc — Kansas City, Kansas, United States
• Cardiovascular Consultants of Kansas — Wichita, Kansas, United States
• Delmarva Heart Research Foundation Inc — Salisbury, Maryland, United States
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
• Minneapolis VA Health Care System — Minneapolis, Minnesota, United States
• Jackson Heart Clinic — Jackson, Mississippi, United States
• Cox Medical Center South — Springfield, Missouri, United States
• Saint Louis University Hospital — St Louis, Missouri, United States
• Glacier View Research Institute Cardiology — Kalispell, Montana, United States
• CHI Health Cardiology (Bergen) — Omaha, Nebraska, United States
• Englewood Hospital & Medical Center — Englewood, New Jersey, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• The Valley Hospital — Ridgewood, New Jersey, United States
• Phoenix Heart, PLLC — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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