AMPLATZER Duct Occluder II Additional Sizes



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:10/19/2018
Start Date:June 5, 2017
End Date:June 2021
Contact:Kimberly Behning
Email:kbehning@sjm.com
Phone:651-756-5622

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

AMPLATZER Duct Occluder II Additional Sizes (ADO II AS) Clinical Study

The ADO II AS Study is a single arm, prospective, multicenter, nonrandomized, open-label
study to characterize the safety and effectiveness of the ADO II AS device in patients with a
patent ductus arteriosus (PDA). Subjects will be implanted with the ADO II AS device using a
transcatheter femoral vessel approach under fluoroscopic and echocardiographic guidance.

To account for subject dropout, up to 50 subjects will be enrolled in this clinical
investigation. Up to an additional 150 subjects may be enrolled under continued access. The
clinical investigation will be conducted at up to 10 centers in the United States.

Subjects participating in this clinical investigation will be followed for 3 years. The
expected duration of enrollment is 18 months. The total duration of the clinical
investigation is expected to be 4.5 years.


Inclusion Criteria:

- Diagnosis of a PDA

- PDA ≤ 4mm in diameter

- PDA ≥ 3mm in length

- Subject (or legally authorized representative) is willing to comply with all
pre-procedure, post-procedure, and follow-up testing requirements and provides consent
to participate in the clinical study

Exclusion Criteria:

- Weight < 700 grams at time of the procedure

- Age < 3 days at time of procedure

- Coarctation of the aorta

- Left pulmonary artery stenosis

- Cardiac output that is dependent on right to left shunt through the patent ductus
arteriosus due to pulmonary hypertension

- Intracardiac thrombus

- Active infection requiring treatment at the time of implant

- Female subjects of child bearing potential are either pregnant or desire to become
pregnant within six months post implant

- Other disease process likely to limit survival to less than six (6) months

- Participating in another study for an investigational drug and/or device that may
clinically interfere with this study's endpoints
We found this trial at
9
sites
Orlando, Florida 32806
Principal Investigator: David Nykanen, MD
Phone: 321-841-5365
?
mi
from
Orlando, FL
Click here to add this to my saved trials
700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Darren Berman, MD
Phone: 614-722-4829
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
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Evan Zahn, MD
Phone: 424-315-2297
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Matthew Gillespie, MD
Phone: 267-426-3159
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
3901 Beaubien St
Detroit, Michigan 48201
(313) 745-5437
Principal Investigator: Thomas Forbes, MD
Phone: 313-745-1023
Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
?
mi
from
Detroit, MI
Click here to add this to my saved trials
6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Principal Investigator: Henri Justino, MD
Phone: 832-826-5681
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
Memphis, Tennessee 38105
?
mi
from
Memphis, TN
Click here to add this to my saved trials
Saint Louis, Missouri 63110
Principal Investigator: Toby Rockefeller, MD
Phone: 314-454-6147
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Principal Investigator: Thomas Jones, MD
Phone: 206-987-3839
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
?
mi
from
Seattle, WA
Click here to add this to my saved trials