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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Native Outflow Tract Transcatheter Pulmonary Valve Research Clinical Study

Conditions
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Congenital Heart Disease, Tetralogy of Fallot

Intervention / Treatment
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* Device: Native Outflow Tract TPV


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Native Outflow Tract TPV<br>Implantation of the Native Outflow Tract TPV | Device: Native Outflow Tract TPV<br>* Transcatheter placement of a pulmonary valve<br>* Other names: Native TPV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of radial, linear and axial compression, bending and torsion of device | The following variables will be measured: radial compression, linear compression, axial compression, device bending and device torsion using the discharge CT. The degree of deformation of the device will be reported. | 4 Days Post-Implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients with Procedural Success | The number of patients who are successfully implanted with the device will be reported. This is measured by meeting all of the following criteria: Confirmation that the device is fixated within the desired location, RV-PA peak-to-peak gradient is less than 25 mmHg, Pulmonary regurgitation is moderate or less, and the subject is free of explantation at 24 hours post-implant. | 24 hours post-implant | 
| Number of Patients with Serious Procedural Adverse Events | The number of patients that experience a serious procedural adverse event, as defined per the study protocol, will be reported. | Through 5 year follow-up | 
| Number of Patients with Device-related Adverse Events | The number of patients that experience a device-related adverse event, as defined per the study protocol, will be reported. | Through 5 years | 
| Number of Patients with Stent Fracture | The number of patients that experience a stent fracture of their device will be reported. | Through 5 years | 
| Number of Patients with Catheter Re-intervention on the TPV | The number of patients that experience a catheter re-intervention will be reported. | Through 5 years | 
| Assessment of Surgical Intervention on the TPV | The number of patients that undergo a surgical intervention will be reported. | Through 5 years | 
| Number of Patient Deaths (all-cause, procedural, and device-related) | Any patient deaths that occur during the study will be reported. | Through 5 years | 
| Pulmonary Regurgitant Fraction (%) as measured by cardiac MRI | The pulmonary regurgitant fraction for all patients, as measured by cardiac MRI, will be reported. | Through 5 years | 
| Pulmonary Regurgitation Severity as Measured by Echocardiography | The pulmonary regurgitation severity for all patients, as measured by echocardiography, will be reported. | Through 5 years | 
| Right Ventricular Volume (ml) as Measured by Cardiac MRI | The right ventricular volumes for all patients, as measured by cardiac MRI, will be reported. | Through 5 years | 
| Mean RVOT Gradient (mmHg) as Measured by Color Wave Doppler | The mean RVOT gradient for all patients, as measured by Color Wave Doppler, will be reported. | Through 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary valve, Congenital heart disease, Transcatheter pulmonary valve, Percutaneous pulmonary valve