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 |
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.
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
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700 Childrens Drive
Columbus, Ohio 43205
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....
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
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...
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South 34th Street
Philadelphia, Pennsylvania 19104
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...
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3901 Beaubien St
Detroit, Michigan 48201
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...
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6621 Fannin St
Houston, Texas 77030
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...
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Orlando, Florida 32806
Principal Investigator: David Nykanen, MD
Phone: 321-841-5365
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Saint Louis, Missouri 63110
Principal Investigator: Toby Rockefeller, MD
Phone: 314-454-6147
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4800 Sand Point Way NE
Seattle, Washington 98105
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...
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