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Purpose

The purpose of this study is to evaluate the hypothesis that valve dysfunction of the Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) System is within the performance goal of 25% in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.

Conditions

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Weight ≥ 20 kg (44 lbs.)
  • Subject presents with at least moderate PR and/or mean RVOT gradient ≥ 35 mmHg.
  • The subject/subject's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria

  • Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 2 weeks after discontinuation of antibiotics)
  • History of or active endocarditis (active treatment with antibiotics) within the past 180 days
  • Leukopenia (WBC < 2000 cells/µL), anemia (Hgb < 7 g/dL), thrombocytopenia (Platelets < 50,000 cells/µL) or any known blood clotting disorder
  • Inappropriate anatomy for femoral introduction and delivery of the SAPIEN 3 THV

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
TPVI
Transcatheter Pulmonary Valve Implantation with the SAPIEN 3 THV
  • Device: SAPIEN 3 THV
    SAPIEN 3 THV in the pulmonic position

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40536

More Details

NCT ID
NCT02744677
Status
Recruiting
Sponsor
Edwards Lifesciences

Study Contact

Veronica Pettigrew, RN
949-250-4116
Veronica_Pettigrew@Edwards.com

Detailed Description

The purpose of this study is to demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3 THV System in subjects with a dysfunctional RVOT conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention. In addition patients with dysfunctional THV will be enrolled in a separate registry.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.