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Multicenter Study of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 THV With the Alterra Adaptive Prestent
Study ID: STU 082017-081
Summary
This is a single arm, prospective, multicenter study. up to 60 subjects will be enrolled at up to 25 sites in the uS and Canada. Subjects will be assessed at the following intervals: screening/baseline, discharge, 30 days, 6 months, 12 months and annually thereafter through 5 years. Subjects enrolled under eFS protocol versions 1.0 and 2.0 will count towards enrollment. The objective of this study is to demonstrate the safety and effectiveness of the edwards alterra adaptive Prestent in conjunction with the edwards SaPien 3 THV System in subjects with a dysfunctional RVoT/pulmonary valve (PV) who are indicated for treatment of PR. Primary endpoint: The primary endpoint is THV dysfunction at 6 months. THV dysfunction is defined as a non-hierarchical composite of: *RVoT/PV re-intervention Secondary endpoints for Labeling: The following secondary endpoints will be evaluated for labeling purposes: *improvement in total PR from baseline to 30 days *Moderate or greater total PR via Transthoracic echocardiography (TTe)
Participant Eligibility
Inclusion Criteria:
- The candidate/candidate's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
- Weight is ≥ 20 kg (44 lbs).
- The patient has a dysfunctional RVOT/PV.
- RVOT/PV proximal and distal landing zone diameter ≥ 27 mm and ≤ 38 mm and/or minimum of 35 mm from contractile tissue to lowest pulmonary artery takeoff.
Exclusion Criteria:
- Active infection requiring current antibiotic therapy (if temporary illness, patient 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 introduction and delivery of the Alterra Adaptive Prestent or the SAPIEN 3 THV.
- Cancer Related
- No
- Healthy Volunteers
- No
- UT Southwestern Principal Investigator
- Vasiliki V Dimas
Pulmonary Disease, Transpulmonary Valve Replacement, Pulmonary Stenosis, TPVR, Tetralogy of Fallot, Congenital Heart Disease
To demonstrate the safety and effectiveness of the edwards alterra adaptive Prestent in conjunction with the edwards SaPien 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract/pulmonary valve (RVoT/PV) who are indicated for treatment of pulmonary regurgitation (PR).
