Atrial Fibrillation Clinical Trial
Official title:
REVEAL AF: Incidence of AF in High Risk Patients
Verified date | March 2018 |
Source | Medtronic Cardiac Rhythm and Heart Failure |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 446 |
Est. completion date | January 30, 2017 |
Est. primary completion date | January 13, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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) Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Austria | LKH - Universitätsklinikum Graz | Graz | |
Austria | Allgemein öffentliches Krankenhaus der Elisabethinen Linz | Linz | |
Germany | Klinikum Coburg GmbH | Coburg | |
Germany | Universitätsklinikum Düsseldorf | Düsseldorf | |
Germany | Universitätsmedizin Göttingen Georg-August-Universität | Gottingen | |
Germany | Asklepios Klinik Sankt Georg | Hamburg | |
Germany | Klinikum Lünen St.-Marien-Hospital GmbH - Akademisches Lehrkrankenhaus der Westfälischen Wilhelms-Un | Lünen | |
Germany | Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen | Tübingen | |
Italy | Azienda Ospedaliera San Gerardo | Monza | |
Italy | Ospedale classificato ed equiparato Sacro Cuore - Don Calabria | Negrar | |
Italy | Ospedale civile di Ciriè | Torino | |
Netherlands | Catharina Ziekenhuis | Eindhoven | |
Netherlands | St. Antonius Ziekenhuis | Nieuwegein | |
Slovenia | University Medical Centre Ljubljana | Ljubljana | |
Spain | Hospital Universitari de Tarragona Joan XXIII | Tarragona | |
United States | The Heart Care Group PC (Allentown PA) | Allentown | Pennsylvania |
United States | Premier HealthCare | Bloomington | Indiana |
United States | Bradenton Cardiology | Bradenton | Florida |
United States | Selcuk A. Tombul, D.O., F.A.C.C. | Chattanooga | Tennessee |
United States | Baylor Heart & Vascular Hospital | Dallas | Texas |
United States | Englewood Hospital & Medical Center | Englewood | New Jersey |
United States | Cardiovascular Consultants Heart Center | Fresno | California |
United States | North Georgia Heart Foundation | Gainesville | Georgia |
United States | The Cardiac & Vascular Institute | Gainesville | Florida |
United States | Caromont Regional Medical Center | Gastonia | North Carolina |
United States | Sutherland Cardiology Clinic | Germantown | Tennessee |
United States | The Stern Cardiovascular Foundation | Germantown | Tennessee |
United States | Phoenix Heart, PLLC | Glendale | Arizona |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | Jackson Heart Clinic | Jackson | Mississippi |
United States | Glacier View Research Institute Cardiology | Kalispell | Montana |
United States | The University Kansas Medical Center Research Institute Inc | Kansas City | Kansas |
United States | Cardiac Clinic | Kissimmee | Florida |
United States | Turkey Creek Medical Center | Knoxville | Tennessee |
United States | Minneapolis Heart Institute Foundation | Minneapolis | Minnesota |
United States | Minneapolis VA Health Care System | Minneapolis | Minnesota |
United States | Cardiovascular Consultants PC (Munster IN) | Munster | Indiana |
United States | Icahn School of Medicine at Mount Sinai | New York | New York |
United States | New York-Presbyterian Hospital/Columbia University Medical Center | New York | New York |
United States | Oklahoma Heart Hospital Research Foundation | Oklahoma City | Oklahoma |
United States | CHI Health Cardiology (Bergen) | Omaha | Nebraska |
United States | Desert Heart Rhythm Consultants | Palm Springs | California |
United States | Baylor Research Institute (Plano TX) | Plano | Texas |
United States | The Valley Hospital | Ridgewood | New Jersey |
United States | Saint Louis University Hospital | Saint Louis | Missouri |
United States | Northside Hospital | Saint Petersburg | Florida |
United States | Salem Cardiovascular Associates | Salem | Oregon |
United States | Delmarva Heart Research Foundation Inc | Salisbury | Maryland |
United States | Nanticoke Cardiology | Seaford | Delaware |
United States | Cox Medical Center South | Springfield | Missouri |
United States | Woodlands North Houston Heart and Vein Center | The Woodlands | Texas |
United States | Lourdes Cardiology Services | Voorhees | New Jersey |
United States | South County Cardiology | Wakefield | Rhode Island |
United States | ProHealth Care | Waukesha | Wisconsin |
United States | Cardiovascular Consultants of Kansas | Wichita | Kansas |
United States | Healdsburg Cardiology | Windsor | California |
United States | Lankenau Institute for Medical Research | Wynnewood | Pennsylvania |
United States | Saint Elizabeth Youngstown Hospital | Youngstown | Ohio |
Lead Sponsor | Collaborator |
---|---|
Medtronic Cardiac Rhythm and Heart Failure |
United States, Austria, Germany, Italy, Netherlands, Slovenia, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 18 Month Incidence Rate of Atrial Fibrillation (AF) Lasting Six or More Minutes | 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. | Implant to 18 months post device insertion | |
Secondary | Predictors of the Incidence of AF | 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. | Time from implant to date of last stored available device data (maximum of 30 months) | |
Secondary | Actions Taken in Response to Awareness of AF | Clinical actions taken in response to clinician awareness of a patient's AF onset or progression will be summarized | Time from first identified episode of AF to study exit (maximum of 30 months) |
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