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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
SAPIEN 3/SAPIEN 3 Ultra RESILIA THV in the pulmonic position
SAPIEN 3 THV in the pulmonic position
SAPIEN 3 Ultra RESILIA THV in the pulmonic position
Arkansas Children's Hospital
Little Rock, Arkansas, United States
RECRUITINGUniversity of California, Los Angeles
Los Angeles, California, United States
COMPLETEDUniversity of California,, San Francisco (UCSF)
San Francisco, California, United States
RECRUITINGChildrens Hospital of Colorado
Aurora, Colorado, United States
THV dysfunction
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
Time frame: 1 year
Device Success
Defined as a composite of: 1) Single THV implanted in the desired location, 2) RV-PA peak-to-peak gradient \< 35 mmHg post-implantation, 3) Less than moderate PR by discharge TTE (or earliest evaluable TTE), 4) Free of explant at 24 hours post-implantation.
Time frame: Discharge, expected to be within 1-5 days post-procedure
Mean RVOT gradient
Time frame: 6 months
Paravalvular and total PR
Time frame: 6 months
RVOT reintervention
Time frame: 6 months
Coronary artery compression requiring intervention
Time frame: 30 days
Major vascular complications
Time frame: 30 days
Life-threatening or disabling bleeding
Time frame: 30 days
THV frame fracture
Time frame: 6 months
Device-related endocarditis
Time frame: 1 year
Death (all-cause, procedural and device-related)
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Emory University/Children's Healthcare of Atlanta
Atlanta, Georgia, United States
RECRUITINGUniversity of Kentucky
Lexington, Kentucky, United States
WITHDRAWNMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGBoston Children's Hospital
Boston, Massachusetts, United States
RECRUITINGMayo Clinic Rochester
Rochester, Minnesota, United States
RECRUITINGSt. Louis Children's Hospital
St Louis, Missouri, United States
RECRUITING...and 15 more locations