Cardiovascular Diseases, Congenital Abnormalities, Heart Defects, Congenital, Heart Diseases, Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis
Conditions
Keywords
Tetralogy of Fallot, Aortic Valve Defect/Disease Resulting in Ross Procedure, Transcatheter pulmonary valve implantation, Transcatheter pulmonary valve replacement, Pulmonary Atresia, Pulmonary Stenosis
Brief summary
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.
Detailed description
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.
Interventions
DEVICESAPIEN XT THV
SAPIEN XT THV will be implanted in the pulmonic position.
Sponsors
Edwards Lifesciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Patient has a dysfunctional, non-compliant RVOT conduit. 2. The patient/patient'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. Inability to tolerate an anticoagulation/antiplatelet regimen 2. Active bacterial endocarditis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from device- or procedure-related death or reintervention | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in pulmonary regurgitation to mild or less for regurgitant lesions | 1 year | Assessed via transthoracic echocardiogram (TTE) |
| Decrease in RVOT mean gradient to less than 30 mmHg for stenotic lesions | 1 year | Assessed via TTE |
| Device Success | 48 Hours Prior to Discharge | 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. |
Countries
United States
Outcome results
None listed