Compassion: Congenital Multicenter Trial of Pulmonic Valve Regurgitation Studying the SAPIEN Interventional THV
The purpose of this study is to assess the safety and effectiveness of pulmonic THV implantation in subjects with dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation (>3 + pulmonary regurgitation) and/or right ventricular outflow tract conduit obstruction (mean gradient of >35mmHg) by transthoracic echocardiogram.
You may be eligible to participate in this study if you:
- Are equal to or exceed 35 kilograms
- Have an in situ conduit size of ≥ 16 mm and ≤ 24 mm in diameter
- Have moderate or severe pulmonary regurgitation defined as ≥3+ pulmonary regurgitation by TTE or RVOT conduit obstruction with a mean gradient of > 35 mmHg by TTE.
- Are symptomatic as evidenced by cardiopulmonary exercise testing
- As the subject or the subject's legal representative have been informed of the nature of the study, agree to its provisions and have provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site
- Will return for all required post-procedure follow up visits and will comply with protocol-required follow-up visits
- Agree to catheterization if it is determined to be feasible by the treating physician
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via e-mail, please include the title of the study in your message.