REVEAL AF: Incidence of AF in High Risk Patients

Atrial Fibrillation Clinical Trial

Official title:

REVEAL AF: Incidence of AF in High Risk Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01727297
• Other study ID #: REVEAL AF
• Status: Completed
• Phase: N/A
• Start date: November 13, 2012
• Est. completion date: January 30, 2017

Study information

• Verified date: March 2018
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• REVEAL Implantable Cardiac Monitor

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

United States,  Austria,  Germany,  Italy,  Netherlands,  Slovenia,  Spain, 

Outcome

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)