AMPLATZER Duct Occluder II Clinical Study

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.