Study of the Native Outflow Tract Transcatheter Pulmonary Valve (TPV)

Native Outflow Tract Transcatheter Pulmonary Valve Research Clinical Study

The purpose of this early feasibility study is to determine how a new transcatheter pulmonary valve will move and perform once implanted in the right ventricular outflow tract.

Medtronic, Inc. is in the process of developing a novel transcatheter device option for patients with congenital heart disease, without right ventricle-to-pulmonary artery conduits, called the Native Outflow Tract Transcatheter Pulmonary Valve. Given limitations in the animal model to confirm device boundary conditions, this feasibility study is proposed to characterize that information as well as evaluate safety, procedural feasibility and performance data to be used for future development of the device.

Inclusion Criteria:

• Subject has pulmonary regurgitation as per one or more of the following criteria: Severe pulmonary regurgitation as measured by Doppler echocardiography, or Pulmonary regurgitant fraction ≥ 30% as measured by cardiac magnetic resonance imaging
• Clinical indication for surgical placement of a RVOT conduit or bioprosthetic pulmonary valve per one or more of the following criteria: Subject is symptomatic secondary to pulmonary insufficiency (e.g. exercise intolerance, fluid overload) as classified by the Investigator, or Right ventricular end diastolic volume (RVEDV) ≥ 150 ml/m2
• Subject is willing to consent to participate in the study and will commit to completion of all follow-up requirements

Exclusion Criteria:

• Anatomy unable to accommodate a 25 Fr delivery system
• Obstruction of the central veins
• Clinical or biological signs of infection including active endocarditis
• Indicated for intervention of stenosis of the branch pulmonary arteries at time of implant
• Positive pregnancy test at baseline (prior to CT angiography and again prior to implant procedure) in female subjects of child bearing potential
• Patients with right ventricular outflow tract obstruction (RVOTO) lesions surgically treated with a right ventricle-to-pulmonary artery conduit implant
• A major or progressive non-cardiac disease (e.g. liver failure, renal failure, cancer) that results in a life expectancy of less than one year
• Planned implantation of the Native Outflow Tract TPV in the left heart
• RVOT anatomy or morphology that is unfavorable for anchoring
• Known allergy to aspirin, heparin, or nickel
• Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
• Pre-existing prosthetic heart valve or prosthetic ring in any position
• Patient is currently enrolled in another investigational device or drug trial that may influence the outcome of this trial.