This study is evaluating the safety and effectiveness of the SAPIEN 3, SAPIEN 3 Ultra RESILIA, or SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) systems. These devices are being tested in people who have a dysfunctional right ventricular outflow tract (RVOT) conduit or a previously implanted valve in the pulmonic position (the valve between the heart and lungs) that needs intervention. The study aims to see if these valves work well and are safe, with success measured by how well the valve functions after one year. To join, you must weigh at least 44 lbs (20 kg) and have a specific type of dysfunctional RVOT conduit or valve, along with moderate pulmonary regurgitation (blood leaking backward) or a high RVOT gradient (pressure difference).

Study design

This is an interventional study with a planned enrollment of 108 participants. It is evaluating the SAPIEN 3, SAPIEN 3 Ultra RESILIA, or SAPIEN 3/SAPIEN 3 Ultra RESILIA THV in the pulmonic position.

What's involved

Not specified in the trial record.

Compensation

Not stated in the trial record.

Follow-up

The primary endpoint, THV dysfunction, is measured at 1 year, indicating participants will be followed for at least that long after the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.