Alterra: Early Feasibility Study

Condition: Right ventricular outflow tract/pulmonary valve

Eligibility

Key Inclusion Criteria

  • Pediatric or adult patent whose weight is ≥44 lbs
  • Has a dysfunctional RVOT/ pulmonary valve (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 immediately before Alterra Prestent insertion

Key Exclusion Criteria

  • Active infection requiring current antibiotic therapy
  • History of or active endocarditis (active treatment with antibiotics) within the past 180 days
  • Leukopenia, anemia, thrombocytopenia or any known blood clotting disorder

Full Study Name

Multi-Center, Early Feasibility Study of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 Transcatheter Heart Valve With the Alterra Adaptive Prestent (IRB no. 47191)

Summary

The purpose of this study is to evaluate an investigational device called the Edwards Alterra Adaptive Prestent. The study will assess the safety and effectiveness of the Edwards Alterra Adaptive Prestent when used in combination with the SAPIEN 3 Transcatheter Heart Valve (THV) for the treatment of significant regurgitation (backflow of blood) in a dysfunctional right ventricular outflow tract (RVOT). The RVOT is the area that connects the heart to the lungs, located between the right ventricle (a pumping chamber) and pulmonary artery (the blood vessel to the lungs).

The study is an Early Feasibility Study, which means that participants will be one of the first in the world to be treated with the combined devices (Edwards Alterra Prestent and Sapien 3 THV) for this condition.

Financial disclosure: Evan Zahn, MD, the principal investigator, receives payment from the sponsor to cover expenses associated with the conduct of the study, in addition to receiving consulting fees.


Principal Investigator

Evan Zahn, MD

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