AMPLATZER Duct Occluder II Clinical Study



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any - 18
Updated:2/6/2019
Start Date:August 2008
End Date:October 5, 2016

Use our guide to learn which trials are right for you!

Closure of Patent Ductus Arteriosus With the AMPLATZER DUCT Occluder II

The objective of this study is to investigate the safety and effectiveness of the ADO II in
patients with a PDA.


Inclusion Criteria:

- Subject must have diagnosis of a PDA

- Subject must have a PDA < 5.5mm in diameter by angiography

- Subject must have a PDA < 12mm in length by angiography

- Subject must have a PDA > 3mm in length by angiography

- Subject/legally authorized representative must give consent to participate in the
clinical study

- Subject/legally authorized representative must consent to follow-up for the duration
of the clinical study

Exclusion Criteria:

- Subject must not be < 6 kilograms for the procedure

- Subject must not be < 6 months of age

- Subject must not be ≥ 18 years of age

- Subject must not have a descending aorta < 10mm in diameter

- Subject must not have a right to left shunt through the patent ductus arteriosus

- Subject must not have PVR above 8 Woods units or a Rp/Rs >0.4

- Subject must not have intracardiac thrombus

- Subject must not have additional cardiac anomalies requiring surgical or
interventional correction

- Subject must not have history of more than two lower respiratory infections within the
last year (i.e., pneumonia)

- Subject must not have active infection requiring treatment at the time of implant

- Subject must not have contraindication to anticoagulation treatment

- Female subjects of child bearing age must not be pregnant or desire to become pregnant
within six months post implant*

- Subject must not be participating in another study for an investigational drug and/or
device that may clinically interfere with this study's endpoints

- If the subject desires to become pregnant after six months post-implant, further
restriction is at the discretion of their physician.
We found this trial at
25
sites
?
mi
from
Dallas, TX
Click here to add this to my saved trials
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
?
mi
from
Columbus, OH
Click here to add this to my saved trials
2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
?
mi
from
Jackson, MS
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
100 N Mario Capecchi Dr
Salt Lake City, Utah 84132
(801) 662-1000
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Diego, California 92123
?
mi
from
San Diego, CA
Click here to add this to my saved trials
1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Aurora, Colorado 80045
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Boston, Massachusetts 02115
?
mi
from
Boston, MA
Click here to add this to my saved trials
Bronx, New York 10467
?
mi
from
Bronx, NY
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
?
mi
from
Houston, TX
Click here to add this to my saved trials
705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
2200 Children's Way
Nashville, Tennessee 37232
(615) 936-1000
Vanderbilt Children's Hospital Monroe Carell Jr. Children's Hospital at Vanderbilt is one of the nation's...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New York, New York 10029
?
mi
from
New York, NY
Click here to add this to my saved trials
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Francisco, California 94143
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
?
mi
from
Washington,
Click here to add this to my saved trials
?
mi
from
Wilmington, DE
Click here to add this to my saved trials