SAPIEN 3/SAPIEN 3 Ultra RESILIA THV: SAPIEN 3/SAPIEN 3 Ultra RESILIA THV in the pulmonic position
SAPIEN 3 THV: SAPIEN 3 THV in the pulmonic position
SAPIEN 3 Ultra RESILIA THV: SAPIEN 3 Ultra RESILIA THV in the pulmonic position
Study summary
This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems 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.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Weight ≥ 20 kg (44 lbs.)
2. Dysfunctional RVOT conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention and with a landing zone diameter ≥ 16.5 mm and ≤ 29 mm immediately prior to study device insertion as per the Instructions for Use
3. Subject presents with at least moderate PR and/or mean RVOT gradient ≥ 35 mmHg.
4. 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:
1. Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 2 weeks after discontinuation of antibiotics)
2. History of or active endocarditis (active treatment with antibiotics) within the past 180 days
3. Leukopenia, anemia, thrombocytopenia or any known blood clotting disorder
4. Inappropriate anatomy for femoral introduction and delivery of the study valve
5. Need for concomitant atrial septal defect or ventricular septal defect closure or other concomitant interventional procedures other than pulmonary artery or branch pulmonary artery stenting or angioplasty
6. Angiographic evidence of coronary artery compression that would result from transcatheter pulmonic valve implantation (TPVI)
7. Interventional/surgical procedures within 30 days prior to the TPVI procedure.
8. Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the TPVI procedure.
9. History of or current intravenous drug use
10. Major or progressive non-cardiac disease resulting in a life expectancy of less than one year
11. Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications
12. Known hypersensitivity to cobalt-chromium, nickel or contrast media that cannot be adequately premedicated
13. Participating in another investigational drug or device study that has not reached its primary endpoint.
14. Female who is lactating or pregnant
Primary outcome measure(s)
THV dysfunction — 1 year Defined as a non-hierarchical composite of: RVOT reintervention, Moderate or greater total pulmonary regurgitation (PR) via Transthoracic Echocardiography (TTE), Mean RVOT gradient \> 40 mmHg via TTE
Trial sites (27)
Facility
City
Region
Status
University of Alabama at Birmingham
Birmingham
Alabama
Recruiting
Arkansas Children's Hospital
Little Rock
Arkansas
Recruiting
University of California, Los Angeles
Los Angeles
California
Completed
University of California,, San Francisco (UCSF)
San Francisco
California
Recruiting
Childrens Hospital of Colorado
Aurora
Colorado
Recruiting
Emory University/Children's Healthcare of Atlanta
Atlanta
Georgia
Recruiting
University of Kentucky
Lexington
Kentucky
Withdrawn
Massachusetts General Hospital
Boston
Massachusetts
Recruiting
Boston Children's Hospital
Boston
Massachusetts
Recruiting
Mayo Clinic Rochester
Rochester
Minnesota
Recruiting
St. Louis Children's Hospital
St Louis
Missouri
Recruiting
Washington University Barnes- Jewish Medical/ St. Louis Children's Hospital
St Louis
Missouri
Completed
Columbia University Medical Center/NYPH
New York
New York
Recruiting
Duke University Medical Center
Durham
North Carolina
Recruiting
The Lindner Research Center at Christ Hospital
Cincinnati
Ohio
Completed
Cincinnati Children's Hospital
Cincinnati
Ohio
Recruiting
Nationwide Children's Hospital
Columbus
Ohio
Recruiting
Penn Presbyterian Medical Center, University of Pennsylvania/ Children's Hospital of Philadelphia
Philadelphia
Pennsylvania
Completed
UPMC Children's Hospital of Pittsburgh
Pittsburgh
Pennsylvania
Recruiting
LeBonheur Children's Hopsital
Memphis
Tennessee
Recruiting
Vanderbilt University
Nashville
Tennessee
Recruiting
Medical City Dallas
Dallas
Texas
Recruiting
Children's Health System of Texas / UT Southwestern Medical Center
Dallas
Texas
Recruiting
Methodist San Antonio
San Antonio
Texas
Recruiting
Intermountain Heart Institute (IMC)
Murray
Utah
Recruiting
University of Virginia (UVA)
Charlottesville
Virginia
Recruiting
University of Washington/Seattle Children's Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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