Food Allergy Center

Children's Health Dallas

Congenital Heart Defects

Pulmonary Valve Insufficiency

Newborn Respiratory Distress Syndrome

Respiratory Distress Syndrome

Syndrome

Acute Lung Injury

Heart Diseases

Tetralogy of Fallot

Sugammadex

Rocuronium

Edwards Lifesciences

The University of Texas System (UT)

University of Pennsylvania

condition

allSponsorName

gender

Male

Female

overallStatus

Recruiting

Not yet recruiting

Active, not recruiting

Enrolling by invitation

Completed

Terminated

Withdrawn

Suspended

Unknown

type

Interventional

Observational

Expanded Access

phase

Early Phase 1

Phase 1

Phase 2

Phase 3

Phase 4

Not Applicable

funderTypes

Industry

Other U.S. Federal agency

All others

ageGroup

Child (birth-17)

Adult (18-64)

Older Adult (65+)

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.

ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent

Children's Health Dallas | Food Allergy Center

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Active trials

ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent

Trial sponsors