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Multicenter Study of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 THV With the Alterra Adaptive Prestent

Multicenter Study of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 THV With the Alterra Adaptive Prestent

  • 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.

If you are interested in this clinical trial, please contact Bianca Mobley on the Children’s Health Research Team.Call 214-456-3929Email