REVEAL AF: Incidence of AF in High Risk Patients
- Conditions
- Atrial Fibrillation
- Interventions
- Device: REVEAL Implantable Cardiac Monitor
- Registration Number
- NCT01727297
- Lead Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 446
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description REVEAL Implantable Cardiac Monitor REVEAL Implantable Cardiac Monitor -
- Primary Outcome Measures
Name Time Method 18 Month Incidence Rate of Atrial Fibrillation (AF) Lasting Six or More Minutes Implant to 18 months post device insertion Incidence of adjudicated AF lasting six or more minutes at 18 months. Each arrhythmic episode detected by the patient's Reveal device will be reviewed to determine if it is 1) an actual atrial fibrillation episode, and (2) is at least 6 minutes in duration. The first such episode per patient occurring within 18 months will be utilized to determine the 18 month incidence rate.
- Secondary Outcome Measures
Name Time Method Predictors of the Incidence of AF Time from implant to date of last stored available device data (maximum of 30 months) AF will be defined as in the primary outcome. Baseline characteristics including demographics, medical history, and biomarkers at enrollment will be tested for their association with a patient's risk of developing AF.
Actions Taken in Response to Awareness of AF Time from first identified episode of AF to study exit (maximum of 30 months) Clinical actions taken in response to clinician awareness of a patient's AF onset or progression will be summarized
Trial Locations
- Locations (58)
Baylor Heart & Vascular Hospital
🇺🇸Dallas, Texas, United States
Cardiovascular Consultants Heart Center
🇺🇸Fresno, California, United States
Desert Heart Rhythm Consultants
🇺🇸Palm Springs, California, United States
Nanticoke Cardiology
🇺🇸Seaford, Delaware, United States
Premier HealthCare
🇺🇸Bloomington, Indiana, United States
Northside Hospital
🇺🇸Saint Petersburg, Florida, United States
North Georgia Heart Foundation
🇺🇸Gainesville, Georgia, United States
Cardiovascular Consultants PC (Munster IN)
🇺🇸Munster, Indiana, United States
The University Kansas Medical Center Research Institute Inc
🇺🇸Kansas City, Kansas, United States
Saint Elizabeth Youngstown Hospital
🇺🇸Youngstown, Ohio, United States
Caromont Regional Medical Center
🇺🇸Gastonia, North Carolina, United States
LKH - Universitätsklinikum Graz
🇦🇹Graz, Austria
ProHealth Care
🇺🇸Waukesha, Wisconsin, United States
Universitätsmedizin Göttingen Georg-August-Universität
🇩🇪Gottingen, Germany
Universitätsklinikum Düsseldorf
🇩🇪Düsseldorf, Germany
Klinikum Coburg GmbH
🇩🇪Coburg, Germany
Asklepios Klinik Sankt Georg
🇩🇪Hamburg, Germany
Cardiovascular Consultants of Kansas
🇺🇸Wichita, Kansas, United States
Minneapolis VA Health Care System
🇺🇸Minneapolis, Minnesota, United States
Oklahoma Heart Hospital Research Foundation
🇺🇸Oklahoma City, Oklahoma, United States
Bradenton Cardiology
🇺🇸Bradenton, Florida, United States
The Cardiac & Vascular Institute
🇺🇸Gainesville, Florida, United States
Cardiac Clinic
🇺🇸Kissimmee, Florida, United States
Healdsburg Cardiology
🇺🇸Windsor, California, United States
Phoenix Heart, PLLC
🇺🇸Glendale, Arizona, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Delmarva Heart Research Foundation Inc
🇺🇸Salisbury, Maryland, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
Jackson Heart Clinic
🇺🇸Jackson, Mississippi, United States
Saint Louis University Hospital
🇺🇸Saint Louis, Missouri, United States
Cox Medical Center South
🇺🇸Springfield, Missouri, United States
Englewood Hospital & Medical Center
🇺🇸Englewood, New Jersey, United States
The Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
New York-Presbyterian Hospital/Columbia University Medical Center
🇺🇸New York, New York, United States
The Heart Care Group PC (Allentown PA)
🇺🇸Allentown, Pennsylvania, United States
Salem Cardiovascular Associates
🇺🇸Salem, Oregon, United States
South County Cardiology
🇺🇸Wakefield, Rhode Island, United States
Lankenau Institute for Medical Research
🇺🇸Wynnewood, Pennsylvania, United States
Baylor Research Institute (Plano TX)
🇺🇸Plano, Texas, United States
Turkey Creek Medical Center
🇺🇸Knoxville, Tennessee, United States
Woodlands North Houston Heart and Vein Center
🇺🇸The Woodlands, Texas, United States
Azienda Ospedaliera San Gerardo
🇮🇹Monza, Italy
Klinikum Lünen St.-Marien-Hospital GmbH - Akademisches Lehrkrankenhaus der Westfälischen Wilhelms-Un
🇩🇪Lünen, Germany
Catharina Ziekenhuis
🇳🇱Eindhoven, Netherlands
Allgemein öffentliches Krankenhaus der Elisabethinen Linz
🇦🇹Linz, Austria
St. Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
Ospedale classificato ed equiparato Sacro Cuore - Don Calabria
🇮🇹Negrar, Italy
Ospedale civile di Ciriè
🇮🇹Torino, Italy
Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
University Medical Centre Ljubljana
🇸🇮Ljubljana, Slovenia
Hospital Universitari de Tarragona Joan XXIII
🇪🇸Tarragona, Spain
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Lourdes Cardiology Services
🇺🇸Voorhees, New Jersey, United States
Glacier View Research Institute Cardiology
🇺🇸Kalispell, Montana, United States
Selcuk A. Tombul, D.O., F.A.C.C.
🇺🇸Chattanooga, Tennessee, United States
CHI Health Cardiology (Bergen)
🇺🇸Omaha, Nebraska, United States
The Stern Cardiovascular Foundation
🇺🇸Germantown, Tennessee, United States
Sutherland Cardiology Clinic
🇺🇸Germantown, Tennessee, United States