Rate of Atrial Fibrillation Through 12 Months in Patients With Recent Ischemic Stroke of Presumed Known Origin



Status:Recruiting
Conditions:Atrial Fibrillation, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:50 - Any
Updated:2/17/2019
Start Date:March 2016
End Date:July 2022
Contact:Christine Greening, MS
Email:christine.j.greening@medtronic.com
Phone:303-840-4074

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Stroke AF - Rate of Atrial Fibrillation Through 12 Months in Patients With Recent Ischemic Stroke of Presumed Known Origin

The purpose of the Stroke AF study is to compare the incidence of atrial fibrillation (AF)
through 12 months between continuous cardiac rhythm monitoring with the Reveal LINQ™
Insertable Cardiac Monitor (ICM) (continuous monitoring arm) and standard of care (SoC)
medical treatment (control arm) in subjects with a recent ischemic stroke of presumed known
origin.

Stroke AF is a prospective, multi-site, randomized, controlled, non-blinded, post-market
study. The Stroke AF study will compare the incidence rate of atrial fibrillation through 12
months between the continuous monitoring arm and the control arm in subjects with a recent
ischemic stroke of presumed known origin. Subjects randomized to the continuous monitoring
arm will have a Reveal LINQ Insertable Cardiac Monitor inserted within 10 days of the
qualifying stroke and undergo continuous remote monitoring. Subjects randomized to the
control arm will be followed per site specific standard of care.

Inclusion Criteria:

- Subject has had an ischemic stroke believed to be due to small vessel disease, large
vessel cervical or intracranial atherosclerosis within the past 10 days

- Subject is willing and able to undergo study requirements and expected to be
geographically stable during study follow-up

- Subject is 60 years of age or older, or age 50 to 59 years plus a documented medical
history of at least one of the following additional risk factors for stroke:

- Congestive heart failure

- Hypertension (Systolic Blood Pressure > 140)

- Diabetes Mellitus

- Prior Stroke (>90 days ago, other than study qualifying index event)

- Vascular disease (e.g. coronary artery disease, heart attack, peripheral artery
disease and complex aortic plaque)

Exclusion Criteria:

- Subject has had a cryptogenic stroke

- Subject has had a cardioembolic stroke

- Subject has untreated hyperthyroidism

- Subject has had a recent myocardial infarction <1 month of stroke

- Subject has had a recent cardiac surgery (e.g. coronary artery bypass surgery (CABG))
<1 month of stroke

- Subject has a mechanical heart valve

- Subject has valvular disease requiring immediate surgical intervention

- Subject has documented prior history of atrial fibrillation or atrial flutter

- Subject has permanent indication for oral anticoagulation

- Subject has permanent contraindication to oral anticoagulation such that detection of
AF would not change medical management, based on enrolling investigators judgment

- Subject is enrolled in a concurrent study that may confound the results of this study.
Co-enrollment in any concurrent clinical study (including registries) requires
approval of the study manager or designee.

- Subject's life expectancy is less than 1 year

- Subject is pregnant

- Subject has or is indicated for implant with a pacemaker, Implantable Cardioverter
Defibrillator (ICD), Cardiac ResynchronizationTherapy (CRT), or an implantable
hemodynamic monitor

- Subject with a medical condition that precludes the patient from participation in the
opinion of the investigator
We found this trial at
37
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3333 Riverbend Drive
Springfield, Oregon 97477
Principal Investigator: Elaine Skalabrin, MD
Phone: (541) 912-6653
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Scott Silverman, MD
Phone: (617) 643-3874
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: Scott Kasner, MD
Phone: (215) 661-4904
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Albany, New York 12208
Principal Investigator: Rizwan Alimohammad, MD
Phone: (518) 292-6053
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20880 West Dixie Highway
Aventura, Florida 33180
Principal Investigator: Howard Kreger, MD
Phone: 305-759-1881
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Birmingham, Alabama 35213
Principal Investigator: Chris Rowley, MD
Phone: 205-599-6386
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8170 33rd Avenue South
Bloomington, Minnesota 55425
Principal Investigator: Haitham Hussein, MD
Phone: 651-495-6368
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Buffalo, New York 14260
Principal Investigator: Marilou Ching, MD
Phone: (716) 887-5200
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Frances Caprio, MD
Phone: (312) 503-0492
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Dallas, Texas 75235
Principal Investigator: Mark Johnson, MD
Phone: (214) 648-3748
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3310 Live Oak St
Dallas, Texas 75204
(214) 820-2687
Principal Investigator: Rashedul Hasan, MD
Phone: (214) 820-9907
Baylor Research Institute Baylor Research Institute (BRI) is a dedicated research center for finding prevention...
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Fairfax, Virginia 22031
Principal Investigator: John Cochran, MD
Phone: (703) 269-4759
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301 Wendover Avenue East
Greensboro, North Carolina 27401
Principal Investigator: Pramod Sethi, MD
Phone: (336) 273-2511
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: Subasini Dash, MD
Phone: (551) 996-5722
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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1301 Punchbowl St
Honolulu, Hawaii 96813
(808) 538-9011
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Queen's Medical Center The Queen's Medical Center, located in downtown Honolulu, Hawaii, is a private,...
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Principal Investigator: John J. Volpi, MD
Phone: (713) 441-7161
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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La Jolla, California 92037
Principal Investigator: Mary Kalafut, MD
Phone: (858) 824-8463
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555 N Duke St
Lancaster, Pennsylvania 17602
(717) 544-5511
Principal Investigator: Murray Flaster, MD
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Lexington, Kentucky 40503
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Louisville, Kentucky 40202
Principal Investigator: Nadeem Talpur, MD
Phone: (502) 446-8544
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Lynchburg, Virginia 24501
Principal Investigator: Matthew Sackett, MD
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Manhasset, New York 11030
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1400 NW 12th Ave
Miami, Florida 33136
(305) 689-5511
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Phone: (305) 243-8018
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Milwaukee, Wisconsin 53215
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Phone: (414) 385-7125
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Nashville, Tennessee 37205
Principal Investigator: Franke LaFranchise, MD
Phone: 615-222-3865
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New Hyde Park, New York 11042
Principal Investigator: Jeffrey Katz, MD
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1514 Jefferson Hwy.
New Orleans, Louisiana 70121
504-842-3000
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Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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New York, New York 10016
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Phone: (212) 263-7704
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
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Orlando, Florida 32804
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450 North New Ballas Road
Saint Louis, Missouri 63141
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1665 Utica Avenue South
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3801 South National Avenue
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99 Beauvoir Avenue
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Wynnewood, Pennsylvania 19096
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