The purpose of the study is to evaluate the safety and effectiveness of the PULSTA Transcatheter Pulmonary Valve (TPV) System for the treatment of congenital or acquired pulmonary valve stenosis and/or regurgitation who require pulmonary valve replacement.
Who can participate
Age range10 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Body weight greater than or equal to 30 kilograms
* Pulmonary regurgitation moderate or severe pulmonary regurgitation or pulmonary valve stenosis with mean gradient \>35mmHg by echocardiography
* Main pulmonary artery trunk of ≥16 mm and ≤30 mm
* Patients willing to provide written informed consent and comply with follow-up evaluations.
Exclusion Criteria:
* Females of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant up until 6 months after TPV implantation
* Pre-existing mechanical valve in pulmonary position or require concomitant repair of other cardiac valves
* Obstruction of the central veins to be approached for the TPV implantation
* Coronary artery compression confirmed by angiography
* A known severe allergy to Nickel
* A known hypersensitivity to any anticoagulation therapy, contrast agent or a hemorrhagic disease
* Suspected active infectious disease (e.g. endocarditis, meningitis)
* Life expectancy of less than 6 months
What they're measuring
1
Procedural/Device related serious adverse events at 6 months