VenusP-Valve Pivotal Study (PROTEUS STUDY)

Официальное название

Evaluation of the Performance of the VenusP-ValveTM System in Patients with Native RVOT Dysfunction

Обзор

A prospective, multi-center, non-randomized interventional study to evaluate the safety and effectiveness of the VenusP-ValveTM System in patients with native right ventricular outflow tract (RVOT) dysfunction. Post procedure, a clinical visit will be scheduled at pre-discharge, 30 days, 6 months, 12 months, and annually thereafter to 10 years. About 60 subjects will be enrolled in this study. Data analysis will be performed after all enrolled subjects complete 6-month follow-up and the primary endpoint analysis report will be submitted to FDA for PMA approval.

Вмешательства

• Устройство Transcatheter pulmonary valve implantation (TPVI)
  A valve is implanted through a catheter (a narrow tube) and inserted through the femoral vein into the right atrium, right ventricle and pulmonary artery. After careful positioning, the valve is implanted by inflating a set of a balloons on the delivery catheter or self-expanding. After the catheter has been removed, the incision is closed with stitches, which are removed after the area has healed.
• Устройство VenusP-ValveTM System
  VenusP-ValveTM System consists of two components: 1. Transcatheter Pulmonary Valve (TPV) 2. Delivery System (DS) including Delivery Catheter System (DCS) and Compression Loading System (CLS) The TPV consists of a self-expanding nitinol stent with a single layer tri-leaflet porcine pericardium tissue. For the Delivery Catheter System (DCS) , the distal (deployment) end of the system features an atraumatic, radiopaque tip. A protective sheath (capsule) covers and maintains the TPV in a crimped p

Первичные конечные точки

• The rate of procedure or device related mortality at the 30 days follow-up visit post procedure [Срок оценки: At 30 Days Post Procedure]
• The rate of re-intervention and acceptable hemodynamic function at 6 Month follow-up visit post procedure [Срок оценки: At 6 Months Post Procedure]

Вторичные конечные точки (7)

• The rate of all-cause mortality, procedure or device related mortality, and procedure or device related Major Adverse Cardiac and Cerebrovascular Events (MACCE) out to 10 years [Срок оценки: Through Ten Years Post Procedure]
• The rate of technical Success during the procedure [Срок оценки: During the Procedure]
• The rate of acceptable hemodynamic performance at 30 days, 1-5 years, 7 years and 10 years. [Срок оценки: At 30 Days, 1-5 Years, 7 Years and 10 Years Post Procedure]
• The rate of procedure success out to 30 days [Срок оценки: At 30 Days Post Procedure]
• The rate of valve dysfunction out to 10 years [Срок оценки: Through Ten Years Post Procedure]
• New York Heart Association (NYHA) classification Through out to 10 years [Срок оценки: Through Ten Years Post Procedure]
• Characterization of quality-of-life scores out to 5 year, and at 10 years [Срок оценки: Through Five Years Post Procedure, and at 10 Years Post Procedure]

Критерии участия

Критерии включения

• Weight ≥25kg (55 lbs.)
• Age ≥ 12 years olds
• Patients have a dysfunctional native RVOT with severe pulmonary regurgitation (i.e., severe pulmonary regurgitation as determined by echocardiography or pulmonary regurgitant fraction ≥30% as determined by cardiac magnetic resonance imaging) and without significant pulmonary stenosis (significant pulmonary stenosis is defined as gradient more than 25mmHg) and are clinically indicated for intervention:

1\) For symptomatic patients, fitting the following criteria:

• Severe pulmonary regurgitation measured by echocardiogram or pulmonary regurgitant fraction ≥30% measured by CMR 2) For asymptomatic patients, including any 2 of the following criteria:
• Mild or moderate RV or LV systolic dysfunction.
• Severe RV dilation (RVEDVI ≥145 mL/m2 or RVESVI ≥ 75 mL/m2or RVEDV >2 × LVEDV).
• Progressive reduction in objective exercise tolerance. 4. Patient is willing to consent to participate in the study and will commit to completion of all follow-up requirements.

Критерии исключения

• Clinical or biological signs of infection including active endocarditis.
• Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
• Leukopenia, anemia, thrombocytopenia, or any known blood clotting disorder, deemed clinically significant after consultation with Haemato-oncology specialists.
• Inappropriate anatomy for femoral or right internal jugular vein (RIJ) introduction and delivery of the VenusP-ValveTM System.
• RVOT anatomy or morphology that is unfavorable for device anchoring.
• Anatomy unable to accommodate VenusP-Valve delivery system.
• Angiographic evidence of coronary artery compression that would result from transcatheter pulmonary valve replacement (TPVR).
• Emergency interventional/surgical procedures within 30 days prior to the index procedure.
• Planned significant and relevant concomitant procedure at time of VenusP-Valve implant.
• Any planned interventional/surgical procedures to be performed within the 30 days follow-up from VenusP-Valve implant.
• Known history of intravenous drug abuse in the past 5 years, without certificate of completion of rehabilitation from a specialist.
• Major or progressive non-cardiac disease resulting in a life expectancy of less than one year.
• Known hypersensitivity or contraindication to antiplatelet, antithrombotic medications, or nitinol (titanium or nickel) leading to be unable to undergo index procedure per physicians' judgement
• Positive pregnancy test at baseline (prior to CT angiography and again prior to implant procedure) in female patients of child-bearing potential.
• Currently participating in an investigational drug or another device study.
• Patient or guardian unwilling or unable to provide written informed consent or comply with follow-up requirements.
• The investigators consider that the patients are not suitable to participate in this research.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Venusmedtech of America — Irvine

Идентификаторы

NCT: NCT06010563 · VTPR-22-07

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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