Force. The finalized document is approved by the CPG for publication in the European Heart
Journal. The Guidelines were developed after careful consideration of the scientific and …

Background Meeting increased regulatory requirements for clinical evaluation of medical
devices marketed in Europe in accordance with the Medical Device Regulation (EU …

Valvular disease remains a major cause of cardiovascular morbidity and mortality
worldwide. 1 Over the past decade, catheter-based interventions in valvular disease have …

Right ventricular outflow tract (RVOT) dysfunction is common following surgical repair of
tetralogy of Fallot and other forms of complex congenital heart disease. This results in …

Background There are limited published data focused on outcomes of transcatheter
pulmonary valve replacement (TPVR) with either a Sapien XT or Sapien 3 (S3) valve …

Objectives The aim of this study was to demonstrate the safety and functionality of the Alterra
Adaptive Prestent and SAPIEN 3 transcatheter heart valve (THV) in patients with …

Background: The Harmony transcatheter pulmonary valve (TPV) was designed for treatment
of postoperative pulmonary valve regurgitation in patients with repaired right ventricular …

Objectives: This study sought to determine the safety and feasibility of transcatheter
pulmonary valve replacement (TPVR) using the Melody valve in native (nonconduit) right …

Abstract Background and Aims Transcatheter pulmonary valve implantation (TPVI) is
indicated to treat right-ventricular outflow tract (RVOT) dysfunction related to congenital heart …

The initial clinical evaluation of the Harmony transcatheter pulmonary valve (TPV) was
conducted under the auspices of the Harmony early feasibility study (EFS)(Native Outflow …