Pulmonary Insufficiency, Pulmonary Regurgitation, Pulmonary Stenosis
Conditions
Keywords
Conduit, Pulmonic, Stenosis, Regurgitation, Dysfunctional
Brief summary
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.
Detailed description
Consecutive patient data should be collected at discharge, 6 months, 12 months and 2-5 years post-implant.
Interventions
DEVICETranscatheter Pulmonic Valve Replacement (TPVR) (Edwards SAPIEN™ THV)
The Edwards SAPIEN™ THV is a biological heart valve manufactured with treated bovine pericardial tissue that is mounted into a balloon expandable stainless steel open cell stent. The Edwards SAPIEN™ THV is available in two sizes (23 and 26mm) and is designed for transcatheter implantation in patients with regurgitant pulmonary valved conduit with or without stenosis. This device is commercially available and is used according the current IFU.
Sponsors
Edwards Lifesciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 6 months | Procedure/Device Success and Freedom from device or procedure related death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Effectiveness | 6 Months | Freedom from device or procedure related SAE and functional improvement |
Countries
Belgium, Germany, Ireland, Israel, Italy, Poland, Saudi Arabia, Turkey (Türkiye), United Kingdom
Outcome results
None listed