ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent (NCT03130777) | Clinical Trial Compass
Active β Not RecruitingNot Applicable
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
United States86 participantsStarted 2017-08-22
Plain-language 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).
Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
Who can participate
SexALL
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Inclusion criteria
β. 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.
β. Weight is β₯ 20 kg (44 lbs).
β. RVOT/PV with moderate or greater PR by TTE.
β. RVOT/PV proximal and distal landing zone diameter β₯ 27 mm and β€ 38 mm, and minimum of 35 mm from contractile tissue to lowest pulmonary artery takeoff.
Exclusion criteria
β. Active infection requiring current antibiotic therapy (if temporary illness, patient may be a candidate 2 weeks after discontinuation of antibiotics).
β. History of or active endocarditis (active treatment with antibiotics) within the past 180 days.
β. Leukopenia (WBC \< 2000 cells/ΞΌL), anemia (Hgb \< 7 g/dL), thrombocytopenia (platelets \< 50,000 cells/ΞΌL) or any known blood clotting disorder.
β. Inappropriate anatomy for introduction and delivery of the Alterra Adaptive Prestent or the SAPIEN 3 THV.
β. Need for concomitant atrial septal defect or ventricular septal defect closure or other concomitant interventional procedures other than pulmonary artery or branch pulmonary artery stenting or angioplasty
β. Interventional/surgical procedures within 30 days prior to the Alterra or valve implant procedure
β. Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the Alterra or valve implant procedure