Study of HeartR PDA Heart Device Safety and Function
Part of Genetic & congenital, Heart & circulation clinical trials.
This study follows patients who had a small heart device (HeartR PDA Occluder) placed to close an opening in their heart called a PDA. Researchers will check how well the device is working and track the patient's health over time.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You had a PDA (a small opening in the heart) diagnosed before surgery
- You had the HeartR PDA Occluder device implanted (placed in your heart)
- You were at least 6 months old when you had the implant
- You weighed at least 6 kg (about 13 lbs) when you had the implant
- The opening in your heart was at least 2 mm wide before the device was placed
- You completed at least one follow-up visit after leaving the hospital
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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