Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Abbott Medical Devices
Age
0–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
NOTE: This study is enrolling children and all local laws and governing IRB requirements will be followed for obtaining informed consent
You may not be if
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
Clareo Health | AMPLATZER Duct Occluder II Additional Sizes
