PULSTA Transcatheter Pulmonary Valve Pre-Approval Study

The PULSTA TPV is a self-expandable valve with flared-ends to adapt to the larger native right ventricular outflow tract (RVOT) and is using a relatively low profile delivery catheter from knitted nitinol wire backbone and trileaflets made from treated porcine pericardial tissue, and a delivery system, which provides access to the right ventricular outflow tract through blood vessels. Consecutive subject data should be collected at discharge, 1, 6 months, and 1-5 years post PULSTA TPV implantation.

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