This study will confirm the safety and effectiveness of the Edwards Lifesciences SAPIEN XT Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular outflow tract (RVOT) conduit with a clinical indication for intervention in a post-market setting.
The study is a prospective, non-randomized, multi-center clinical study to assess the safety and effectiveness of pulmonic implantation of the SAPIEN THV in patients with dysfunctional RVOT conduits requiring treatment for moderate or severe pulmonary regurgitation (PR) by transthoracic echocardiography (TTE) and/or RVOT conduit obstruction with a mean gradient of ≥ 35 mmHg by TTE.
Study Type
OBSERVATIONAL
Enrollment
57
SAPIEN XT THV will be implanted in the pulmonic position.
University of Alabama
Birmingham, Alabama, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Advocate Children's Hospital
Oak Lawn, Illinois, United States
The University of Iowa
Iowa City, Iowa, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Children's Heart Center Nevada
Las Vegas, Nevada, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Mount Sinai Beth Israel
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
...and 2 more locations
Freedom from device- or procedure-related death or reintervention
Time frame: 1 year
Decrease in pulmonary regurgitation to mild or less for regurgitant lesions
Assessed via transthoracic echocardiogram (TTE)
Time frame: 1 year
Decrease in RVOT mean gradient to less than 30 mmHg for stenotic lesions
Assessed via TTE
Time frame: 1 year
Device Success
Device Success is a composite of: * Deployment of the valve to the target area, and * Removal of the delivery catheter out of the body, and * Improvement in pulmonary regurgitation to mild or less per the earliest evaluable TTE.
Time frame: 48 Hours Prior to Discharge
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