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.
Congenital Heart Disease, Tetralogy of Fallot
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.
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
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.
Native Outflow Tract TPV
August 7, 2020
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
For more information and to contact the study team: