PULSTA Transcatheter Pulmonary Valve Pre-Approval Study

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the safety and effectiveness of the PULSTA Transcatheter Pulmonary Valve (TPV) System for the treatment of congenital or acquired pulmonary valve stenosis and/or regurgitation who require pulmonary valve replacement.

Detailed Description
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The PULSTA TPV is a self-expandable valve with flared-ends to adapt to the larger native right ventricular outflow tract (RVOT) and is using a relatively low profile delivery catheter from knitted nitinol wire backbone and trileaflets made from treated porcine pericardial tissue, and a delivery system, which provides access to the right ventricular outflow tract through blood vessels. Consecutive subject data should be collected at discharge, 1, 6 months, and 1-5 years post PULSTA TPV implantation.

Official Title
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The PULSTA Transcatheter Pulmonary Valve (TPV) Pre-Approval Study

Conditions
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Heart Diseases, Pulmonary Valve Regurgitation, Pulmonary Valve Stenosis, Tetralogy of Fallot

Intervention / Treatment
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* Device: PULSTA TPV System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body weight greater than or equal to 30 kilograms Pulmonary regurgitation moderate or severe pulmonary regurgitation or pulmonary valve stenosis with mean gradient >35mmHg by echocardiography Main pulmonary artery trunk of ≥16 mm and ≤30 mm Patients willing to provide written informed consent and comply with follow-up evaluations. Exclusion Criteria: Females of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant up until 6 months after TPV implantation Pre-existing mechanical valve in pulmonary position or require concomitant repair of other cardiac valves Obstruction of the central veins to be approached for the TPV implantation Coronary artery compression confirmed by angiography A known severe allergy to Nickel A known hypersensitivity to any anticoagulation therapy, contrast agent or a hemorrhagic disease Suspected active infectious disease (e.g. endocarditis, meningitis) Life expectancy of less than 6 months

Ages Eligible for Study
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Minimum Age: 10 Years

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PULSTA TPV<br>PULSTA Transcatheter Pulmonary Valve (TPV) System | Device: PULSTA TPV System<br>* PULSTA transcatheter pulmonary valve replacement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural/Device related serious adverse events at 6 months |  | 6 months | 
| Hemodynamic functional improvement at 6 months | Hemodynamic functional improvement is a composite of mean RVOT gradient ≤30 mmHg by continuous wave Doppler and a pulmonary regurgitant fraction <20% by cardiac magnetic resonance (MR) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Success | Procedural success is defined as the TPV implant within desired position, Right ventricle-Pulmonary artery (RV-PA) peak systolic pressure gradient <35mmHg by catheter, less mild pulmonary regurgitation by angiography, and freedom from explantation of the TPV at 24 hours post-implant. | 7 days | 
| Hemodynamic Function | Hemodynamic function will be assessed including peak RVOT pressure gradient, mean RVOT pressure gradient, right ventricle (RV) end-diastolic volume index by echocardiography or cardiac MR. | 5 years | 
| Pulmonary Regurgitant Fraction | Pulmonary regurgitant fraction (PRF) will be assessed via cardiac MRI at 6 months after the PULSTA TPV implantation. | 6months | 
| Severity of Pulmonary Regurgitation | Severity of pulmonary regurgitation will be assessed via Doppler echocardiography. | 5 years | 
| NYHA functional classification | Clinical outcome will be assessed as per the New York Heart Association (NYHA) functional classification t all follow-up visits and will be compared to baseline values. | 5 years | 
| Catheter reintervention on TPV | Catheter re-intervention on PULSTA TPV is defined as any interventional catheter procedure (e.g. balloon angioplasty) that alters or adjusts, or replaces a previously implanted PULSTA TPV during a 5-year follow-up period, and the frequency will be evaluated. | 5 years | 
| Reoperation | Reoperation is defined as open surgery that alters or adjusts, or replaces a previously implanted PULSTA TPV during a 5-year follow-up period, and the frequency will be evaluated. | 5 years | 
| Procedural / Device related serious adverse events |  | 5 years | 
| Death (All cause / procedural/device-related) |  | 5 years | 
| Other adverse events |  | 5 years |