Pulmonic Valve REplacement Multi-discIpline EMEA Registry (PREMIER)

Edwards Lifesciences

Status: Completed

Conditions: Pulmonary Stenosis; Pulmonary Regurgitation; Pulmonary Insufficiency

Treatments: Device: Transcatheter Pulmonic Valve Replacement (TPVR) (Edwards SAPIEN™ THV)

Study type: Observational

Funder types: Industry

Identifiers

NCT01356108

2010-11

Details and patient eligibility

About

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.

Full description

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

Enrollment: 127 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.