Pulmonic Valve REplacement Multi-discIpline EMEA Registry

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.

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Key information

Conditions

Pulmonary Regurgitation Cardiovascular Diseases Constriction, Pathologic Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Heart Diseases Heart Valve Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pulmonary Insufficiency Pulmonary Stenosis Pulmonary Valve Insufficiency Pulmonary Valve Stenosis Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Ventricular Outflow Obstruction

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Leuven, Leuven, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcatheter Pulmonic Valve Replacement (TPVR) (Edwards SAPIEN™ THV)

Device

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.

Primary outcomes

Safety

Time frame: 6 months

Procedure/Device Success and Freedom from device or procedure related death

Secondary outcomes

Safety and Effectiveness

Time frame: 6 Months

Freedom from device or procedure related SAE and functional improvement

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study title

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

Acronym: PREMIER

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2017
First posted: May 19, 2011
Registry last updated: Nov 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed