VenusP-Valve Pivotal Study (PROTEUS STUDY)

About

Brief Summary

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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 2/Phase 3

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

12 Years

Maximum Age

N/A

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.