Congenital Multicenter trial of Pulmonic Valve dysfunction studying the SAPIEN 3 interventional THV.

STuDY DeSiGn: This is a single arm, prospective, multicenter, pivotal study at up to 25 sites predominantly in the uS. The following cohorts will be evaluated: Main Cohort: a total of 58 subjects with a dysfunctional RVoT conduit or surgical valve will be enrolled using SaPien 3 THV. one roll-in subject is allowed per site but not required; roll-in subjects will not be counted towards the enrolled sample size. no site will be allowed to enroll more than 30% of subjects. [enrollment is complete.] THV-in-THV Registry: up to 50 subjects with a dysfunctional THV will be enrolled using either SaPien 3 or SaPien 3 ultra ReSiLia THV. SaPien 3 ultra ReSiLia Registry: a total of 58 subjects with a dysfunctional RVoT conduit or surgical valve will be enrolled using the SaPien 3 ultra ReSiLia THV. no site will be allowed to enroll more than 30% of subjects. all subjects will be assessed at the following intervals: screening/baseline, discharge, 30 days, 6 months, 12 months and annually thereafter through 5 years. enrollment duration in the Main Cohort with SaPien 3 was 2 years; it is expected that enrollment in the SaPien 3 ultra ReSiLia Registry will be the same. enrollment in the THV-in-THV Registry is ongoing and is expected to take approximately 8 years to complete. Thus, with subject follow-up continuing through 5 years, the resulting total study duration is approximately 14 years. STuDY DuRaTion: Subjects will be assessed at Screening/baseline, discharge, 30 days, 6 months, 12 months and annually thereafter through 5 years. STuDY DeViCeS: edwards SaPien 3 ultra ReSiLia THV (20, 23, 26 and 29 mm) edwards Commander Delivery System and accessories Refer to the current instructions for use (iFu) for descriptions, indications for use, contraindications, system preparation, precautions and warnings. STuDY ouTCoMeS: Device Success, defined as a composite of: * Single THV implanted in the desired location * Right ventricle to pulmonary artery (RV-Pa) peak-to-peak gradient [Less Than] 35 mmHg post-implantation * Less than moderate PR by discharge TTe (or earliest evaluable TTe) * Free of explant at 24 hours post-implantation THV dysfunction at 1 year, defined as a non-hierarchical composite of: * RVoT reintervention note: Reintervention includes surgical and catheter-based procedures * Moderate or greater total PR via TTe * Mean RVoT gradient [Greater Than] 40 mmHg via TTe THV hemodynamic function at 6 months: * Mean RVoT gradient via TTe * Paravalvular and total PR via TTe * RVoT reintervention echocardiographic assessments at 30 days, 6 months, 12 months, 2 years, 3 and 5 years. nYHa functional class at 30 days, 6 months, 12 months, 2, 3 and 5 years. eCG at 6 months. in addition, adverse events will be summarized.