Atrial FibrillationNCT01727297

REVEAL AF: Incidence of AF in High Risk Patients

A study testing REVEAL Implantable Cardiac Monitor in people with Atrial Fibrillation, run by Medtronic Cardiac Rhythm and Heart Failure at 58 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Fibrillation
What is being tested?: REVEAL Implantable Cardiac Monitor
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 446 participants
Where: 58 sitesin 7 countries
Study dates: 13 Nov 2012to 30 Jan 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Show all 14Show fewer

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

Trial locations and contacts

58 sites in 7 countries.

Country

City, postcode or hospital

58 sites in 7 countries

United States43 sites

The Heart Care Group PC (Allentown PA)
Allentown, Pennsylvania, 18103-6202
Premier HealthCare
Bloomington, Indiana, 47403-3239
Bradenton Cardiology
Bradenton, Florida, 34205-8805
Selcuk A. Tombul, D.O., F.A.C.C.
Chattanooga, Tennessee, 37404
Baylor Heart & Vascular Hospital
Dallas, Texas, 75226-1301
Englewood Hospital & Medical Center
Englewood, New Jersey, 07631-1808
Cardiovascular Consultants Heart Center
Fresno, California, 93720-3235
The Cardiac & Vascular Institute
Gainesville, Florida, 32605-4218
North Georgia Heart Foundation
Gainesville, Georgia, 30501-3427
Caromont Regional Medical Center
Gastonia, North Carolina, 28054-2140
The Stern Cardiovascular Foundation
Germantown, Tennessee, 38138-1727
Sutherland Cardiology Clinic
Germantown, Tennessee, 38138-1760
Phoenix Heart, PLLC
Glendale, Arizona, 85306-1870
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Jackson Heart Clinic
Jackson, Mississippi, 39216-4634
Glacier View Research Institute Cardiology
Kalispell, Montana, 59901
The University Kansas Medical Center Research Institute Inc
Kansas City, Kansas, 66160-8500
Cardiac Clinic
Kissimmee, Florida, 34741
Turkey Creek Medical Center
Knoxville, Tennessee, 37934
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407-1195
Minneapolis VA Health Care System
Minneapolis, Minnesota, 55417-2309
Cardiovascular Consultants PC (Munster IN)
Munster, Indiana, 46321-4054
Icahn School of Medicine at Mount Sinai
New York, New York, 10029-6574
New York-Presbyterian Hospital/Columbia University Medical Center
New York, New York, 10032-3725
Oklahoma Heart Hospital Research Foundation
Oklahoma City, Oklahoma, 73120
CHI Health Cardiology (Bergen)
Omaha, Nebraska, 68124-2319
Desert Heart Rhythm Consultants
Palm Springs, California, 92262
Baylor Research Institute (Plano TX)
Plano, Texas, 75093-3691
The Valley Hospital
Ridgewood, New Jersey, 07450-2726
Salem Cardiovascular Associates
Salem, Oregon, 97302
Delmarva Heart Research Foundation Inc
Salisbury, Maryland, 21804-6951
Nanticoke Cardiology
Seaford, Delaware, 19973
Cox Medical Center South
Springfield, Missouri, 65807-5251
Saint Louis University Hospital
St Louis, Missouri, 63110-2539
Northside Hospital
St. Petersburg, Florida, 33709
Woodlands North Houston Heart and Vein Center
The Woodlands, Texas, 77384-4167
Lourdes Cardiology Services
Voorhees Township, New Jersey, 08043
South County Cardiology
Wakefield, Rhode Island, 02879-4253
ProHealth Care
Waukesha, Wisconsin, 53188
Cardiovascular Consultants of Kansas
Wichita, Kansas, 67226
Healdsburg Cardiology
Windsor, California, 95492
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, 19096-3450
Saint Elizabeth Youngstown Hospital
Youngstown, Ohio, 44504-1006

Other trials in United States

Germany6 sites

Klinikum Coburg GmbH
Coburg, 96450
Universitätsklinikum Düsseldorf
Düsseldorf, 40225
Universitätsmedizin Göttingen Georg-August-Universität
Göttingen, 37075
Asklepios Klinik Sankt Georg
Hamburg, 20099
Klinikum Lünen St.-Marien-Hospital GmbH - Akademisches Lehrkrankenhaus der Westfälischen Wilhelms-Un
Lünen, 44534
Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen
Tübingen, 72076

Other trials in Germany

Italy3 sites

Azienda Ospedaliera San Gerardo
Monza, 20090
Ospedale classificato ed equiparato Sacro Cuore - Don Calabria
Negrar, 37024
Ospedale civile di Ciriè
Torino, 10073

Other trials in Italy

Austria2 sites

LKH - Universitätsklinikum Graz
Graz, 8036
Allgemein öffentliches Krankenhaus der Elisabethinen Linz
Linz, 4010

Other trials in Austria

Netherlands2 sites

Catharina Ziekenhuis
Eindhoven, 5623 EJ
St. Antonius Ziekenhuis
Nieuwegein, 3430 EM

Other trials in Netherlands

Slovenia1 site

University Medical Centre Ljubljana
Ljubljana, 1000

Other trials in Slovenia

Spain1 site

Hospital Universitari de Tarragona Joan XXIII
Tarragona, 43007

Other trials in Spain

About this study

Conditions: Atrial Fibrillation
Being tested: REVEAL Implantable Cardiac Monitor
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

REVEAL Implantable Cardiac MonitorDevice

Study groups in NCT01727297
Study group	Role	What they receive
REVEAL Implantable Cardiac Monitor	Other	Not described Receives: Device: REVEAL Implantable Cardiac Monitor

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Implant to 18 months post device insertion

Secondary outcomes (2)

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.
Measured: Time from implant to date of last stored available device data (maximum of 30 months)
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
Measured: Time from first identified episode of AF to study exit (maximum of 30 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Nov 201230 Jan 2017

First posted15 Nov 2012 (estimated)
Study start13 Nov 2012
Primary completion13 Jan 2017
Study completion30 Jan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 446 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01727297
Sponsor's protocol ID: REVEAL AF
Status last verified: Mar 2018
First submitted: 12 Nov 2012
Last updated: 30 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 31862084
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.
PubMed 28842973

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: REVEAL AF: Incidence of AF in High Risk Patients
ClinicalTrials.gov ID: NCT01727297
Acronym / sponsor ID: REVEAL AF
Conditions: Atrial Fibrillation
Study type: Interventional
Recruitment status: Completed
Enrolment: 446 participants (actual)
Lead sponsor: Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
Study start: 13 Nov 2012 (actual)
Primary completion: 13 Jan 2017 (actual)
Study completion: 30 Jan 2017 (actual)
First posted: 15 Nov 2012 (estimated)
Results: Posted 29 Mar 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
REVEAL Implantable Cardiac Monitor	Other	Device: REVEAL Implantable Cardiac Monitor

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (14 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
REVEAL Implantable Cardiac Monitor	Device	REVEAL Implantable Cardiac Monitor

Primary outcome

18 Month Incidence Rate of Atrial Fibrillation (AF) Lasting Six or More Minutes
Time frame: 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.

2 secondary outcomes

Predictors of the Incidence of AF
Time frame: Time from implant to date of last stored available device data (maximum of 30 months)
Actions Taken in Response to Awareness of AF
Time frame: Time from first identified episode of AF to study exit (maximum of 30 months)

Results and safety

Results posted to the registry on 29 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Reveal Implantable Cardiac Monitor Implant Attempted	395	293
No Reveal Implantable Cardiac Monitor Implant Attempt	51	0

Primary outcome: 18 Month Incidence Rate of Atrial Fibrillation (AF) Lasting Six or More Minutes

Time frame: Implant to 18 months post device insertion. Number. Unit: percent of participants

Measure	Primary Objective Analysis Cohort n = 385
Value	29.3

Population analysed: This analysis only included patients who received an implantable cardiac monitor, met all inclusion/exclusion criteria, and had device data available. Of the 395 participants who underwent an implant attempt, 1 attempt was unsuccessful, 7 subjects did not meet all inclusion/exclusion criteria, and 2 subjects had no post-implant device data.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events occurring from the time of enrollment (consent) until exit will be included. All subjects were to be followed a minimum of 18 months and a maximum of 30 months post-Reveal device implantation.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Reveal Implantable Cardiac Monitor Implant Attempted	153 of 395 (38.7%)	34 of 395 (8.6%)	13 of 395
No Reveal Implantable Cardiac Monitor Implant Attempt	1 of 51 (2%)	1 of 51 (2%)	0 of 51

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31862084Reiffel 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.
Derived from this study: PubMed 28842973Reiffel 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.
Individual participant dataSharing planned: No

Related trials for Atrial Fibrillation

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

James A Reiffel, MD principal investigator

Columbia University

58 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing REVEAL Implantable Cardiac Monitor in people with Atrial Fibrillation, run by Medtronic Cardiac Rhythm and Heart Failure at 58 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States, Germany, Italy, Austria, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

18 Month Incidence Rate of Atrial Fibrillation (AF) Lasting Six or More Minutes (time frame: Implant to 18 months post device insertion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01727297, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2018.