REVEAL AF: Incidence of AF in High Risk Patients

NCT01727297 | Completed Results FDA Device

• 1 other identifier: REVEAL AF
• Study Type: interventional
• Target: 446
• Locations: 7 countries
• Sites: 58

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Predictors of the Incidence of AF

  Time from implant to date of last stored available device data (maximum of 30 months)

• Actions Taken in Response to Awareness of AF

  Time from first identified episode of AF to study exit (maximum of 30 months)

Study Arms (1)

REVEAL Implantable Cardiac Monitor

OTHER

Device: REVEAL Implantable Cardiac Monitor

Interventions

REVEAL Implantable Cardiac Monitor DEVICE

REVEAL Implantable Cardiac Monitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (58)

Phoenix Heart, PLLC

Glendale, Arizona, 85306-1870, United States

Location

Cardiovascular Consultants Heart Center

Fresno, California, 93720-3235, United States

Location

Desert Heart Rhythm Consultants

Palm Springs, California, 92262, United States

Location

Healdsburg Cardiology

Windsor, California, 95492, United States

Location

Nanticoke Cardiology

Seaford, Delaware, 19973, United States

Location

Bradenton Cardiology

Bradenton, Florida, 34205-8805, United States

Location

The Cardiac & Vascular Institute

Gainesville, Florida, 32605-4218, United States

Location

Cardiac Clinic

Kissimmee, Florida, 34741, United States

Location

Northside Hospital

St. Petersburg, Florida, 33709, United States

Location

North Georgia Heart Foundation

Gainesville, Georgia, 30501-3427, United States

Location

Premier HealthCare

Bloomington, Indiana, 47403-3239, United States

Location

Cardiovascular Consultants PC (Munster IN)

Munster, Indiana, 46321-4054, United States

Location

The University Kansas Medical Center Research Institute Inc

Kansas City, Kansas, 66160-8500, United States

Location

Cardiovascular Consultants of Kansas

Wichita, Kansas, 67226, United States

Location

Delmarva Heart Research Foundation Inc

Salisbury, Maryland, 21804-6951, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407-1195, United States

Location

Minneapolis VA Health Care System

Minneapolis, Minnesota, 55417-2309, United States

Location

Jackson Heart Clinic

Jackson, Mississippi, 39216-4634, United States

Location

Cox Medical Center South

Springfield, Missouri, 65807-5251, United States

Location

Saint Louis University Hospital

St Louis, Missouri, 63110-2539, United States

Location

Glacier View Research Institute Cardiology

Kalispell, Montana, 59901, United States

Location

CHI Health Cardiology (Bergen)

Omaha, Nebraska, 68124-2319, United States

Location

Englewood Hospital & Medical Center

Englewood, New Jersey, 07631-1808, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

The Valley Hospital

Ridgewood, New Jersey, 07450-2726, United States

Location

Lourdes Cardiology Services

Voorhees Township, New Jersey, 08043, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029-6574, United States

Location

New York-Presbyterian Hospital/Columbia University Medical Center

New York, New York, 10032-3725, United States

Location

Caromont Regional Medical Center

Gastonia, North Carolina, 28054-2140, United States

Location

Saint Elizabeth Youngstown Hospital

Youngstown, Ohio, 44504-1006, United States

Location

Oklahoma Heart Hospital Research Foundation

Oklahoma City, Oklahoma, 73120, United States

Location

Salem Cardiovascular Associates

Salem, Oregon, 97302, United States

Location

The Heart Care Group PC (Allentown PA)

Allentown, Pennsylvania, 18103-6202, United States

Location

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, 19096-3450, United States

Location

South County Cardiology

Wakefield, Rhode Island, 02879-4253, United States

Location

Selcuk A. Tombul, D.O., F.A.C.C.

Chattanooga, Tennessee, 37404, United States

Location

The Stern Cardiovascular Foundation

Germantown, Tennessee, 38138-1727, United States

Location

Sutherland Cardiology Clinic

Germantown, Tennessee, 38138-1760, United States

Location

Turkey Creek Medical Center

Knoxville, Tennessee, 37934, United States

Location

Baylor Heart & Vascular Hospital

Dallas, Texas, 75226-1301, United States

Location

Baylor Research Institute (Plano TX)

Plano, Texas, 75093-3691, United States

Location

Woodlands North Houston Heart and Vein Center

The Woodlands, Texas, 77384-4167, United States

Location

ProHealth Care

Waukesha, Wisconsin, 53188, United States

Location

LKH - Universitätsklinikum Graz

Graz, 8036, Austria

Location

Allgemein öffentliches Krankenhaus der Elisabethinen Linz

Linz, 4010, Austria

Location

Klinikum Coburg GmbH

Coburg, 96450, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, 40225, Germany

Location

Universitätsmedizin Göttingen Georg-August-Universität

Göttingen, 37075, Germany

Location

Asklepios Klinik Sankt Georg

Hamburg, 20099, Germany

Location

Klinikum Lünen St.-Marien-Hospital GmbH - Akademisches Lehrkrankenhaus der Westfälischen Wilhelms-Un

Lünen, 44534, Germany

Location

Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Azienda Ospedaliera San Gerardo

Monza, 20090, Italy

Location

Ospedale classificato ed equiparato Sacro Cuore - Don Calabria

Negrar, 37024, Italy

Location

Ospedale civile di Ciriè

Torino, 10073, Italy

Location

Catharina Ziekenhuis

Eindhoven, 5623 EJ, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, 3430 EM, Netherlands

Location

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

Hospital Universitari de Tarragona Joan XXIII

Tarragona, 43007, Spain

Location

Related Publications (2)

• 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.

  PMID: 31862084 DERIVED

• 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.

  PMID: 28842973 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Medtronic Cardiac Rhythm and Heart Failure clinical trial manager
• Organization: Medtronic, Inc.

medtronicCRMtrials@medtronic.com

763-505-6000

Study Officials

• James A Reiffel, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2012
• First Posted: November 15, 2012
• Study Start: November 13, 2012
• Primary Completion: January 13, 2017
• Study Completion: January 30, 2017
• Last Updated: April 30, 2018
• Results First Posted: March 29, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (43); NL (2); DE (6); SL (1); AU (2); IT (3); ES (1)