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

Edwards Lifesciences16 sites in 9 countries127 target enrollmentJanuary 2011

ConditionsPulmonary Regurgitation Pulmonary Insufficiency Pulmonary Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pulmonary Regurgitation
Sponsor: Edwards Lifesciences
Enrollment: 127
Locations: 16
Primary Endpoint: Safety
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2011

End Date

December 19, 2017

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Edwards Lifesciences

Responsible Party

Sponsor

Eligibility Criteria

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.