AMPLATZER PFO Occluder Post Approval Study



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 60
Updated:2/3/2019
Start Date:January 4, 2018
End Date:December 2025
Contact:Maren Wagner
Email:mwagner2@sjm.com
Phone:651 756 5585

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OSB Lead-AMPLATZER PFO Occluder New Enrollment PAS

The purpose of this single arm, multi-center study is to confirm the safety and effectiveness
of the AMPLATZER™ PFO Occluder in the post Approval Setting.

A maximum of 1214 adult subjects will be enrolled at up to 100 centers in the U.S. and
Canada. Subjects will have follow-up at 1 month, 6 months, 12 months and annually thereafter
through 5 years post implant.

Inclusion Criteria:

• Subjects with a PFO who have had an ischemic stroke within the last 270 days

Exclusion Criteria:

- Atherosclerosis or other arteriopathy of the intracranial and extracranial vessels
associated with a > 50% lumen diameter supplying the involved lesion

- Intra-cardiac thrombus or tumor

- Documented evidence of venous thrombus in the vessels through which access to the PFO
is gained

- Acute or recent (within 6 months prior to consent) myocardial infarction or unstable
angina

- Left ventricular aneurysm or akinesis

- Mitral valve stenosis or severe mitral regurgitation requiring intervention
irrespective of etiology

- Aortic valve stenosis (mean gradient >40 mmHg) or severe aortic valve regurgitation

- Mitral or aortic valve vegetation or prosthesis

- Aortic arch plaques protruding greater than 4mm into the aortic lumen

- Left ventricular dilated cardiomyopathy with depressed left ventricular ejection
fraction (LVEF less than 35%)

- Subjects with other source of right to left shunts, including an atrial septal defect
and/or fenestrated septum

- Chronic, persistent, or paroxysmal atrial fibrillation or atrial flutter

- Pregnancy at the time of implant

- Age less than 18 years or greater than 60 years at time of consent

- Active endocarditis or other untreated infections

- Organ failure (kidney, liver or lung) Kidney failure: Poor urine output of less than 1
cc/kg/hr with elevated BUN levels (above the normal reference range for the laboratory
at the investigational site).

Liver failure: Liver enzymes outside the normal reference range for the laboratory at the
investigational site: poor liver function as assessed by elevated PT (above the normal
reference range for the laboratory at the investigational site) and low total protein and
albumin (below the normal reference range for the laboratory at the investigational site).

Lung failure: Respiratory failure is retention of carbon dioxide more than 60 mmHg, poor
oxygenation with oxygen tension less than 40 mmHg in room air or the need for assisted
ventilation.

- Uncontrolled hypertension defined as sustained elevated systemic blood pressure to
more than 160/90 mmHg with medications

- Uncontrolled diabetes defined as continued elevated glucose levels in spite of
administration of insulin/levels of more than 200 mg with presence of glucose in the
urine

- Diagnosis of lacunar infarct probably due to intrinsic small vessel as qualifying
stroke event Definition: Ischemic stroke in the distribution of a single, small deep
penetrating vessel in a patient with any of the following: 1) a history of
hypertension (except in the first week post stroke); 2) history of diabetes mellitus;
3) Age >/= 50; or 4) MRI or CT shows leukoaraiosis greater than symmetric,
well-defined periventricular caps or bands (European Task Force on Age-Related White
Matter Changes rating scale score > 0)

- Arterial dissection as cause of stroke

- Subjects who test positive with one of the following hypercoagulable states;
Anticardiolipin Ab of the IgG or IgM, Lupus anticoagulant, B2-glycoprotein-1
antibodies or persistently elevated fasting plasma homocysteine despite medical
therapy

- Unable to take antiplatelet therapy

- Anatomy in which the AMPLATZERTM PFO Occluder device size required would interfere
with intracardiac or intravascular structures such as valves or pulmonary veins

- Vasculature, through which access to the PFO is gained, is inadequate to accommodate
the appropriate sheath size

- Malignancy or other illness where life expectancy is less than 2 years

- Subjects who will not be available for follow-up for the duration of the trial

- Inability to obtain Informed Consent from patient

- Index stroke of poor outcome (modified Rankin score greater than 3)
We found this trial at
59
sites
Plano, Texas 75093
Principal Investigator: Srinivasa Potluri, MD
Phone: 469-814-4878
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: David Thaler, MD
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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1200 North Elm Street
Greensboro, North Carolina 27401
Principal Investigator: Michael Cooper, MD
Phone: 336-832-3798
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Richard Smalling, MD
Phone: 713-500-5683
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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1 Shircliff Way
Jacksonville, Florida 32204
Principal Investigator: Samer Garas, MD
Phone: 904-450-8645
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Jacksonville, Florida 32207
Principal Investigator: Ruby Satpathy, MD
Phone: 904-202-7218
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24 Sturtevant St
Orlando, Florida 32806
Principal Investigator: VijayKumar Kasi, PhD, MD
Phone: 321-841-3686
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2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
Principal Investigator: Roberto Cubbedu, MD
Phone: 954-659-6247
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Principal Investigator: Spencer Palmer, MD
Phone: 404-686-5734
Emory University Hospital As the largest health care system in Georgia and the only health...
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2701 Cambridge Court
Auburn Hills, Michigan 48326
Principal Investigator: Ahmad Munir, MD
Phone: 810-342-3067
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Augusta, Georgia 30912
Principal Investigator: Zahid Amin, MD
Phone: 706-721-0193
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Chandler, Arizona 85224
Principal Investigator: Nabil Dib, MD
Phone: 866-367-4373
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Charlotte, North Carolina 28204
Principal Investigator: Olseun Alli, MD
Phone: 704-264-1400
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Chattanooga, Tennessee 37403
Principal Investigator: Matthew Wiisanen, MD
Phone: 423-987-6692
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Clifford Kawinsky, MD
Phone: 312-942-1604
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Cincinnati, Ohio 45236
Principal Investigator: Jonathan Rapp, MD
Phone: 513-952-5104
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Konstantinos Boudoulas, MD
Phone: 614-247-7733
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, Ohio 43214
Principal Investigator: Konstantinos Boudoulas, MD
Phone: 614-566-1250
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Columbus, Ohio 43213
Principal Investigator: Kurt Jacobson, MD
Phone: 516-546-4297
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Principal Investigator: James Blankenship, MD
Phone: 570-271-7176
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Denver, Colorado 80220
Principal Investigator: Michael Wahl, MD
Phone: 303-801-3408
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: William O'Neill, MD
Phone: 313-916-3571
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Duluth, Minnesota 55805
Principal Investigator: Wilson Ginete, MD
Phone: 218-786-4868
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Principal Investigator: Mark Kozak, MD
Phone: 717-531-1452
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Indianapolis, Indiana
Principal Investigator: James Hermiller, MD
Phone: 317-338-6450
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Jacksonville, Florida 32256
Principal Investigator: Vaqar Ali, MD
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Knoxville, Tennessee 37934
Principal Investigator: Malcolm Foster, MD
Phone: 865-218-7535
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Lansing, Michigan 48912
Principal Investigator: Gaurav Dhar, MD
Phone: 517-364-5734
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Lee's Summit, Missouri 64018
Principal Investigator: Bangalore Deepak, MD
Phone: 913-253-3022
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Lexington, Kentucky
859) 257-9000
Principal Investigator: John Gurley, MD
Phone: 859-323-5259
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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4733 Sunset Blvd
Los Angeles, California 90027
(800) 954-8000
Principal Investigator: Somjot Brar, MD, MPH
Phone: 323-783-7387
Kaiser Permanente Los Angeles Medical Center We've been there for you in the past, providing...
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Los Angeles, California 90033
Principal Investigator: David Rizik, MD
Phone: 800-872-2273
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Los Angeles, California 90095
Principal Investigator: Jamil Aboulhosn, MD
Phone: 310-825-5950
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Louisville, Kentucky 40207
Principal Investigator: Thomas Tu, MD
Phone: 502-893-7710
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Madison, Wisconsin 53792
Principal Investigator: Kurt Jacobson, MD
Phone: 608-265-0612
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Marietta, Georgia 30106
Principal Investigator: Amar Patel, MD
Phone: 770-793-5147
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Marshfield, Wisconsin 54449
Principal Investigator: Milind Shah, MD
Phone: 715-389-3748
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Milwaukee, Wisconsin 14450
Principal Investigator: Tanvir Bajwa, MD
Phone: 414-649-3439
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Missoula, Montana 59802
Principal Investigator: James Maddux, MD
Phone: 406-329-2797
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1514 Jefferson Hwy.
New Orleans, Louisiana 70121
504-842-3000
Principal Investigator: James Jenkins, MD
Phone: 504-842-5071
Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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New York, New York 10065
Principal Investigator: Geoffrey Bergman, MBBS
Phone: 212-746-2516
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201 Lyons Ave
Newark, New Jersey 07112
(973) 926-7000
Principal Investigator: Marc Cohen, MD
Phone: 973-926-8451
Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
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600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
Principal Investigator: Paul Mahoney, MD
Phone: 757-388-1568
Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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350 W Thomas Rd
Phoenix, Arizona 85013
(602) 406-3000
Principal Investigator: Hursh Naik, MD
Phone: 866-367-4373
St. Joseph's Hospital and Medical Center St. Joseph's is a nationally recognized center for quality...
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Pittsburgh, Pennsylvania 15212
Principal Investigator: David Lasorda, MD
Phone: 412-359-4025
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Portland, Oregon 97220
Principal Investigator: Ethan Korngold, MD
Phone: 503-216-7275
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Sacramento, California 95816
Principal Investigator: David Roberts, MD, FACC
Phone: 916-887-4040
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1406 6th Avenue North
Saint Cloud, Minnesota 56303
Principal Investigator: Jacob Dutcher, MD
Phone: 320-251-2700
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10010 Kennerly Road
Saint Louis, Missouri 63128
Principal Investigator: Christopher Allen, MD
Phone: 314-525-1697
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San Diego, California 92123
Principal Investigator: Raghava Gollapudi, MD
Phone: 858-244-6800
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San Francisco, California 94143
Principal Investigator: Vaikom Mahadevan, MD
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Scottsdale, Arizona 85258
Principal Investigator: David Rizik, MD
Phone: 480-323-0416
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550 17th Avenue
Seattle, Washington 98122
Principal Investigator: Sameer Gafoor, MD
Phone: 206-386-6462
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Springfield, Illinois 62701
Principal Investigator: Nilesh Goswami, MD
Phone: 217-492-9100
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Principal Investigator: David Lee, MD
Phone: 650-723-2094
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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Thousand Oaks, California 91360
Principal Investigator: Vishva Dev, MD
Phone: 805-370-4184
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110 Irving St NW
Washington, District of Columbia 20010
(202) 877-7000
Principal Investigator: Lowell Satler, MD
Phone: 202-877-0149
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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Wichita, Kansas 67226
Principal Investigator: Bassem Chehab, MD
Phone: 316-265-1308
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Winston-Salem, North Carolina 27103
Principal Investigator: Samuel Turner, MD
Phone: 336-718-5807
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