ADVANCE ASO AMPLATZER™ Atrial Septal Occluder Post Market Surveillance Study



Status:Terminated
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:2/6/2019
Start Date:January 19, 2015
End Date:February 24, 2017

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Closure of Atrial Septal Defects With the AMPLATZER™ Septal Occluder (ASO) Post Market Surveillance Study

Prospective, multicenter, case-cohort study.To identify potential risk factors associated
with the occurrence of erosion due to implantation of the AMPLATZER™ Septal Occluder (ASO.)

This study will enroll 8000 subjects. The sub-cohort will consist of 160 (2%) subjects,
randomly selected from the full cohort. The analysis population will consist of all subjects
in the sub-cohort, combined with all subjects with erosion events who are not in the
sub-cohort. A detailed assessment of risk factors will be conducted on the subjects in this
analysis population.

Inclusion Criteria:

To participate in this clinical investigation, the patient must meet all of the following
inclusion criteria:

1. Patient indicated for ASD closure who has echocardiographic evidence of ostium
secundum atrial septal defect and clinical evidence of right ventricular volume
overload (such as, 1.5:1 degree of left-to-right shunt or RV enlargement) and is
implanted with the ASO device Note: This does not include the indication for closure
of a fenestration following a fenestrated Fontan procedure

2. Patient is willing and able to complete the follow-up requirements of this study

3. Patient signs the informed consent (or a legal representative signs the informed
consent.)

Exclusion Criteria:

Patient is not eligible for clinical investigation participation if he/she meets any of the
following exclusion criteria:

1. Patient is known to have extensive congenital cardiac anomaly which can only be
adequately repaired by way of cardiac surgery

2. Patient is known to have sepsis within 1 month prior to implantation, or any systemic
infection that cannot be successfully treated prior to device placement

3. Patient is known to have a bleeding disorder, untreated ulcer, or any other
contraindications to aspirin therapy (unless another anti-platelet agent can be
administered for 6 months)

4. Patient is known to have a demonstrated intracardiac thrombus on echocardiography

5. Patient whose size (such as, too small for transesophageal echocardiography probe,
catheter size) or condition (active infection, etc.) would cause the patient to be a
poor candidate for cardiac catheterization

6. Patient has margins of defect that are less than 5 mm to the coronary sinus, AV valves
or right upper lobe pulmonary vein
We found this trial at
65
sites
4733 Sunset Blvd
Los Angeles, California 90027
(800) 954-8000
Principal Investigator: Morris M Salem, MD
Phone: 323-783-5310
Kaiser Permanente Los Angeles Medical Center We've been there for you in the past, providing...
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Darren Berman, MD
Phone: 614-722-2537
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Columbus, OH
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3533 South Alameda Street
Corpus Christi, Texas 78411
(361) 694-5000
Driscoll Children's Hospital Driscoll Children's Hospital was built because Clara Driscoll's will requested that a...
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Principal Investigator: James Thompson, MD
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: Makram Ebeid, MD
Phone: 601-984-5250
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Jacksonville, Florida 32207
Principal Investigator: Robert English, MD
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Little Rock, Arkansas 72202
Principal Investigator: Michael J Angtuaco, MD
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Principal Investigator: Frank F Ing, MD
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Los Angeles, California 90033
213) 740-2311
Principal Investigator: Ray Matthews Matthews, MD
University of Southern California The University of Southern California is one of the world’s leading...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Matthew J Gillespie, MD
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Thomas K Jones, MD
Phone: 206-221-8049
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Principal Investigator: John Sullebarger, MD
Phone: 813-353-1515
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Principal Investigator: Mohammad El-Hajjar, MD
Phone: 518-262-5076
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Principal Investigator: Christopher Petit, MD
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
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Austin, Texas 78758
Principal Investigator: Manish Chauhan, MD
Phone: 512-807-3160
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Baltimore, Maryland 20742
(301) 405-1000
Principal Investigator: Michael Slack, MD
Phone: 410-328-4348
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Birmingham, Alabama 35294
Principal Investigator: Oluseun O. Alli, MD
Phone: 205-934-7898
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Jesse Esch, MD
Phone: 617-355-6529
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Camp Hill, Pennsylvania 17011
Principal Investigator: Andreas Wali, MD
Phone: 717-724-6450
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Elman Frantz, MD
Phone: 919-966-8072
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Scott Lim, MD
Phone: 434-982-1058
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Clearwater, Florida 33756
Principal Investigator: Saihari Sadanandan, MD
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Patcharapong Suntharos, MD
Phone: 216-444-3701
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Principal Investigator: James Blankenship, MD
Phone: 570-214-1991
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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3901 Beaubien St
Detroit, Michigan 48201
(313) 745-5437
Principal Investigator: Daniel Turner, MD
Phone: 313-745-5835
Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: Adam Greenbaum, MD
Phone: 313-916-1878
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Durham, North Carolina 27705
Principal Investigator: Richard Krasuski, MD
Phone: 919-681-4684
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1001 E 5th St
Greenville, North Carolina 27858
(252) 328-6131
Principal Investigator: Charles J Sang, MD
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Harrisburg, Pennsylvania 17043
Principal Investigator: C. Randolph Hubbard, MD
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Houston, Texas 77030
Principal Investigator: C. Huie Lin, MD
Phone: 713-441-8042
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Houston, Texas 77030
Principal Investigator: Asra Khan, MD
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Principal Investigator: Mark Hoyer, MD
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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Las Vegas, Nevada 89109
Principal Investigator: Abraham Rothman, MD
Phone: 702-990-4812
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: John Robb, MD
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Los Angeles, California 90095
Principal Investigator: Jamil Aboulhosn, MD
Phone: 310-825-5950
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Madera, California 93638
Principal Investigator: Carl Owada, MD
Phone: 559-353-6257
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Madison, Wisconsin 53792
(608) 263-2400
Principal Investigator: Kurt Jacobson, MD
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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2900 W Oklahoma Ave
Milwaukee, Wisconsin 53215
414-649-6000
Principal Investigator: Tanvir Bajwa, MD
Phone: 414-649-6180
Aurora St. Luke's Medical Center At Aurora St. Luke's Medical Center, you'll find remarkable treatment...
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Minneapolis, Minnesota 55404
Principal Investigator: Marko Vezmar, MD
Phone: 612-813-8800
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Principal Investigator: Jeremy Asnes, MD
Phone: 203-785-2022
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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New Hyde Park, New York 11040
Phone: 718-470-7350
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New Orleans, Louisiana 70118
Principal Investigator: Ernest Siwik, MD
Phone: 504-894-5377
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New York, New York 10021
Principal Investigator: Geoffrey Bergman, MD
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New York, New York 10032
Principal Investigator: Alejandro Torres, MD
Phone: 212-305-6069
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New York, New York 10029
Principal Investigator: Barry Love, MD
Phone: 212-241-9516
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4440 West 95th Street
Oak Lawn, Illinois 60453
708.684.8000
Principal Investigator: Alexander Javois, MD
Phone: 708-684-5580
Advocate Christ Medical Center Advocate Health Care, named among the nation
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1100 N. Lindsay
Oklahoma City, Oklahoma 73104
(405) 271-4000
Principal Investigator: Charles Sperrazza, MD
Phone: 405-271-4411
University of Oklahoma The OU Health Sciences Center is composed of seven health-related colleges located...
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Orlando, Florida 32803
Principal Investigator: Rohit Bhatheja, MD
Phone: 407-303-8059
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Orlando, Florida 32806
Principal Investigator: David Nykanen, MD
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Palo Alto, California 94304
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Pasadena, California 91105
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Philadelphia, Pennsylvania 19104
Principal Investigator: Howard Hermann, MD
Phone: 215-662-2180
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3414 Fifth Avenue
Pittsburgh, Pennsylvania 15213
Principal Investigator: Jacqueline Kreutzer, MD
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Saint Louis, Missouri 63110
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Saint Petersburg, Florida 33701
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Salt Lake City, Utah 84143
Principal Investigator: Robert Gray, MD
Phone: 801-359-3599
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San Diego, California 92123
Principal Investigator: John W Moore, MD
Phone: 858-966-5855
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Principal Investigator: Thomas Jones, MD
Phone: 206-987-2266
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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Spokane, Washington 99204
Principal Investigator: Carl Garabedian, MD
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Tucson, Arizona 85721
(520) 621-2211
Principal Investigator: Michael Seckeler, MD
Phone: 520-626-8000
University of Arizona The University of Arizona is a premier, public research university. Established in...
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Principal Investigator: Joshua Kanter, MD
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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West Des Moines, Iowa 50266
Principal Investigator: Mark Tannenbaum, MD
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Wilmington, Delaware 19803
Principal Investigator: Wolfgang Radtke, MD
Phone: 302-651-6640
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