VenusP-Valve Pivotal Study (PROTEUS STUDY)

Official title

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

Overview

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.

Interventions

• Device 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.
• Device 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

Primary outcome measures

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

Secondary outcome measures (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 [Time frame: Through Ten Years Post Procedure]
• The rate of technical Success during the procedure [Time frame: During the Procedure]
• The rate of acceptable hemodynamic performance at 30 days, 1-5 years, 7 years and 10 years. [Time frame: At 30 Days, 1-5 Years, 7 Years and 10 Years Post Procedure]
• The rate of procedure success out to 30 days [Time frame: At 30 Days Post Procedure]
• The rate of valve dysfunction out to 10 years [Time frame: Through Ten Years Post Procedure]
• New York Heart Association (NYHA) classification Through out to 10 years [Time frame: Through Ten Years Post Procedure]
• Characterization of quality-of-life scores out to 5 year, and at 10 years [Time frame: Through Five Years Post Procedure, and at 10 Years Post Procedure]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Venusmedtech of America — Irvine

Identifiers

NCT: NCT06010563 · VTPR-22-07

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗