Clinical trial NCT01727297: REVEAL AF: Incidence of AF in High Risk Patients
Official title: REVEAL AF: Incidence of AF in High Risk Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2012-11-15
Enrollment: 446
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


Eligibility criteria: 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

Primary outcomes:
measure: 18 Month Incidence Rate of Atrial Fibrillation (AF) Lasting Six or More Minutes
timeFrame: Implant to 18 months post device insertion
Secondary outcomes:
measure: Predictors of the Incidence of AF
timeFrame: Time from implant to date of last stored available device data (maximum of 30 months)
measure: Actions Taken in Response to Awareness of AF
timeFrame: Time from first identified episode of AF to study exit (maximum of 30 months)
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Phoenix Heart, PLLC
state: Arizona
city: Fresno
country: United States
facility: Cardiovascular Consultants Heart Center
state: California
city: Palm Springs
country: United States
facility: Desert Heart Rhythm Consultants
state: California
city: Windsor
country: United States
facility: Healdsburg Cardiology
state: California
city: Seaford
country: United States
facility: Nanticoke Cardiology
state: Delaware
city: Bradenton
country: United States
facility: Bradenton Cardiology
state: Florida
city: Gainesville
country: United States
facility: The Cardiac & Vascular Institute
state: Florida
city: Kissimmee
country: United States
facility: Cardiac Clinic
state: Florida
city: Saint Petersburg
country: United States
facility: Northside Hospital
state: Florida
city: Gainesville
country: United States
facility: North Georgia Heart Foundation
state: Georgia
city: Bloomington
country: United States
facility: Premier HealthCare
state: Indiana
city: Munster
country: United States
facility: Cardiovascular Consultants PC (Munster IN)
state: Indiana
city: Kansas City
country: United States
facility: The University Kansas Medical Center Research Institute Inc
state: Kansas
city: Wichita
country: United States
facility: Cardiovascular Consultants of Kansas
state: Kansas
city: Salisbury
country: United States
facility: Delmarva Heart Research Foundation Inc
state: Maryland
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System
state: Minnesota
city: Jackson
country: United States
facility: Jackson Heart Clinic
state: Mississippi
city: Saint Louis
country: United States
facility: Saint Louis University Hospital
state: Missouri
city: Springfield
country: United States
facility: Cox Medical Center South
state: Missouri
city: Kalispell
country: United States
facility: Glacier View Research Institute Cardiology
state: Montana
city: Omaha
country: United States
facility: CHI Health Cardiology (Bergen)
state: Nebraska
city: Englewood
country: United States
facility: Englewood Hospital & Medical Center
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: Voorhees
country: United States
facility: Lourdes Cardiology Services
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: New York-Presbyterian Hospital/Columbia University Medical Center
state: New York
city: Gastonia
country: United States
facility: Caromont Regional Medical Center
state: North Carolina
city: Youngstown
country: United States
facility: Saint Elizabeth Youngstown Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital Research Foundation
state: Oklahoma
city: Salem
country: United States
facility: Salem Cardiovascular Associates
state: Oregon
city: Allentown
country: United States
facility: The Heart Care Group PC (Allentown PA)
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Institute for Medical Research
state: Pennsylvania
city: Wakefield
country: United States
facility: South County Cardiology
state: Rhode Island
city: Chattanooga
country: United States
facility: Selcuk A. Tombul, D.O., F.A.C.C.
state: Tennessee
city: Germantown
country: United States
facility: The Stern Cardiovascular Foundation
state: Tennessee
city: Germantown
country: United States
facility: Sutherland Cardiology Clinic
state: Tennessee
city: Knoxville
country: United States
facility: Turkey Creek Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor Heart & Vascular Hospital
state: Texas
city: Plano
country: United States
facility: Baylor Research Institute (Plano TX)
state: Texas
city: The Woodlands
country: United States
facility: Woodlands North Houston Heart and Vein Center
state: Texas
city: Waukesha
country: United States
facility: ProHealth Care
state: Wisconsin
city: Graz
country: Austria
facility: LKH - Universitätsklinikum Graz
city: Linz
country: Austria
facility: Allgemein öffentliches Krankenhaus der Elisabethinen Linz
city: Coburg
country: Germany
facility: Klinikum Coburg GmbH
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Gottingen
country: Germany
facility: Universitätsmedizin Göttingen Georg-August-Universität
city: Hamburg
country: Germany
facility: Asklepios Klinik Sankt Georg
city: Lünen
country: Germany
facility: Klinikum Lünen St.-Marien-Hospital GmbH - Akademisches Lehrkrankenhaus der Westfälischen Wilhelms-Un
city: Tübingen
country: Germany
facility: Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen
city: Monza
country: Italy
facility: Azienda Ospedaliera San Gerardo
city: Negrar
country: Italy
facility: Ospedale classificato ed equiparato Sacro Cuore - Don Calabria
city: Torino
country: Italy
facility: Ospedale civile di Ciriè
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
city: Tarragona
country: Spain
facility: Hospital Universitari de Tarragona Joan XXIII
Study officials:
affiliation: Columbia University
name: James A Reiffel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reiffel JA, Verma A, Kowey PR, Halperin JL, Gersh BJ, Elkind MSV, Ziegler PD, Kaplon RE, Sherfesee L, Wachter R; REVEAL AF Investigators. Rhythm monitoring strategies in patients at high risk for atrial fibrillation and stroke: A comparative analysis from the REVEAL AF study. Am Heart J. 2020 Jan;219:128-136. doi: 10.1016/j.ahj.2019.07.016.
citation: Reiffel JA, Verma A, Kowey PR, Halperin JL, Gersh BJ, Wachter R, Pouliot E, Ziegler PD; REVEAL AF Investigators. Incidence of Previously Undiagnosed Atrial Fibrillation Using Insertable Cardiac Monitors in a High-Risk Population: The REVEAL AF Study. JAMA Cardiol. 2017 Oct 1;2(10):1120-1127. doi: 10.1001/jamacardio.2017.3180.