- ClinicalTrials.gov ID: NCT03130777
- Not accepting healthy volunteers
- UTSW Principal Investigator: Vasiliki V Dimas
summary
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).
objective
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).
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.