ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent

Status Active, not recruiting

Clinical Trial Summary

To demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract/pulmonary valve (RVOT/PV) who are indicated for treatment of pulmonary regurgitation (PR). Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Congenital Heart Disease
Heart Defects, Congenital
Heart Diseases
Pulmonary Disease
Pulmonary Regurgitation
Pulmonary Valve Insufficiency
Tetralogy of Fallot
Transcatheter Pulmonary Valve Replacement (TPVR)

Clinical Trial Details

NCT number	NCT03130777
Study type	Interventional
Source	Edwards Lifesciences
Contact
Status	Active, not recruiting
Phase	N/A
Start date	August 22, 2017
Completion date	June 2032

View Details

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