Nit-Occlud PDA Post-Approval Study
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any - 21 |
| Updated: | 4/17/2018 |
| Start Date: | August 2014 |
| End Date: | August 2022 |
The Nit-Occlud PDA Post-Approval Study is designed to continue to evaluate the safety and
effectiveness of the device in the post-approval phase.
effectiveness of the device in the post-approval phase.
Inclusion Criteria:
- Angiographically confirmed PDA with minimum diameter < 4 mm.
- Weight is ≥ 5 kg.
- Age 6 months to 21 years.
Exclusion Criteria:
- Cardiac anomalies requiring surgery.
- Known bleeding or coagulation disorder.
- Febrile illness within 7 days of planned procedure.
- Pregnancy.
- Pulmonary hypertension with increased pulmonary vascular resistance (≥ 5 Wood Units).
- Hypersensitivity to contrast medium.
- Known nickel allergy.
We found this trial at
11
sites
4440 West 95th Street
Oak Lawn, Illinois 60453
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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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Phone: 513-636-7072
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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700 Childrens Drive
Columbus, Ohio 43205
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Ralf Holzer, 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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9300 Valley Children's Pl
Madera, California 93720
Madera, California 93720
(559) 353-3000
Principal Investigator: Carl Owada, MD
Phone: 559-353-5476
Children's Hospital Central California The Children's Hospital Central California is a not-for-profit, state-of-the-art children’s hospital...
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South 34th Street
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
215-590-1000
Principal Investigator: Matt Gillespie, MD
Phone: 215-590-1790
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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1935 Medical District Dr
Dallas, Texas 75235
Dallas, Texas 75235
(214) 456-7000
Principal Investigator: Vivian Dimas, MD
Phone: 214-456-8727
Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
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3901 Beaubien St
Detroit, Michigan 48201
Detroit, Michigan 48201
(313) 745-5437
Principal Investigator: Thomas Forbes, 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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11234 Anderson St
Loma Linda, California 92354
Loma Linda, California 92354
(909) 558-4000
Principal Investigator: Brent Gordon, MD
Phone: 909-558-4207
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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Los Angeles, California 90027
Principal Investigator: Morris M Salem, MD
Phone: 323-783-5310
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2450 Riverside Avenue
Minneapolis, Minnesota 55454
Minneapolis, Minnesota 55454
Phone: 612-626-2755
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4800 Sand Point Way NE
Seattle, Washington 98105
Seattle, Washington 98105
(206) 987-2000
Principal Investigator: Thomas K 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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