Le Bonheur Children's Hospital
The objective of this study is to demonstrate the continued safety and efficacy in a real-world setting of transcatheter device closure of the PDA in premature infants less than 2kg in weight at the time of device implant using the Amplatzer Piccolo Occluder device and other devices performed in the USA.
Based on the IMPACT registry, there are over 6000 transcatheter device closures of PDA that occurs in the United States annually. However, there are no comprehensive data collection tools for this procedure. The current databases do not include multiple data points, or follow-up data, or a section for specific adverse events to be documented. Moreover, until now, there has been no approved devices for PDA closure in children \< 2kg. This clinical study is the first of its kind to collect data from all transcatheter device closure of PDA in children \< 2kg performed in the USA.This study will b…
Inclusion Criteria: 1. Diagnosis of PDA. 2. Clinical indication for transcatheter PDA closure (discretion of the physician). 3. Weight \<2 kg at the time of device implant. Exclusion Criteria: 1. Weight \<700 gm or greater than or equal to 2 kg at the time of device implant. 2. Age \< 3 days at the time of device implant. 3. Pre-existing coarctation of the aorta. 4. Pre-existing left pulmonary artery stenosis. 5. Cardiac output that is dependent on right to left shunt through the PDA due to pulmonary hypertension. 6. Intracardiac thrombus that interferes with device implant. 7. Active infec…
Device utilized for closure of PDA, study is to help assure continued safety and effectiveness of FDA approved Amplatzer Piccolo Occluder device as well as other devices used off label for PDA closure in premature infants less than 2 kg at the time of device implant.
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