Pulmonic Valve REplacement Multi-discIpline EMEA Registry

Implantation of the SAPIEN™ Transcatheter Heart Valve (THV) in the Pulmonic Position

The purpose of this registry is to retrospectively and prospectively obtain clinical data in consecutively treated patients, in order to demonstrate that the commercially available Edwards SAPIEN Valve with the RF3 delivery system is a safe and effective treatment for patients with pulmonary regurgitation or stenosis.

Consecutive patient data should be collected at discharge, 6 months, 12 months and 2-5 years post-implant.

Inclusion Criteria:

- Symptomatic with a regurgitant or stenotic pulmonary valved conduit.

Exclusion Criteria:

• Angiographic evidence of coronary artery compression.
• RV-PA pulmonary conduit size that is either too large or too small to accommodate the SAPIEN THV.
• Thrombus or intracardiac mass in the right atrium, right ventricle, and/or pulmonic valve.
• Severe coagulation problems and/or unable to tolerate anticoagulation/antiplatelet therapy.
• Active bacterial endocarditis or other active infections.
• Illeofemoral venous stenosis that may prevent the placement of the introducer sheath and/or central venous vascular tortuosities that may prevent advancement of the delivery system to the heart or into the pulmonary artery.
• Presence of any prosthetic valve in the tricuspid position.
• Unstable coronary artery disease-related angina.
• Placement of the SAPIEN THV in pregnant females.