This trial is active, not recruiting.

Conditions pulmonary regurgitation, pulmonary insufficiency, pulmonary stenosis
Treatment transcatheter pulmonic valve replacement (tpvr) (edwards sapien™ thv)
Sponsor Edwards Lifesciences
Start date January 2011
End date July 2013
Trial size 127 participants
Trial identifier NCT01356108, 2010-11


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

time frame: 6 months

Secondary Outcomes

Safety and Effectiveness
time frame: 6 Months

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title Implantation of the SAPIEN™ Transcatheter Heart Valve (THV) in the Pulmonic Position
Principal investigator Peter Ewert, MD
Description Consecutive patient data should be collected at discharge, 6 months, 12 months and 2-5 years post-implant.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Edwards Lifesciences.