NCT06010563RecruitingNot Applicable
Evaluation of the Performance of the VenusP-ValveTM System in Patients with Native RVOT Dysfunction
Venus MedTech (HangZhou) Inc.1 site in 1 country60 target enrollmentStarted: June 11, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The rate of procedure or device related mortality at the 30 days follow-up visit post procedure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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.
Arms & Interventions
TPVI
Experimental
Intervention: VenusP-ValveTM System (Device)
TPVI
Experimental
Intervention: Transcatheter pulmonary valve implantation (TPVI) (Device)
Outcomes
Primary Outcomes
The rate of procedure or device related mortality at the 30 days follow-up visit post procedure
Time Frame: At 30 Days Post Procedure
Freedom from procedure or device related mortality at 30 days
The rate of re-intervention and acceptable hemodynamic function at 6 Month follow-up visit post procedure
Time Frame: At 6 Months Post Procedure
Freedom from VenusP-Valve re-intervention and acceptable hemodynamic function at 6 months defined as: 1. No more than mild regurgitation measured by CMR; AND 2. Mean RVOT gradient as measured by echocardiography ≤35mmHg.
Secondary Outcomes
- The rate of technical Success during the procedure(During the Procedure)
- 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(Through Ten Years Post Procedure)
- The rate of acceptable hemodynamic performance at 30 days, 1-5 years, 7 years and 10 years.(At 30 Days, 1-5 Years, 7 Years and 10 Years Post Procedure)
- The rate of procedure success out to 30 days(At 30 Days Post Procedure)
- Characterization of quality-of-life scores out to 5 year, and at 10 years(Through Five Years Post Procedure, and at 10 Years Post Procedure)
- New York Heart Association (NYHA) classification Through out to 10 years(Through Ten Years Post Procedure)
- The rate of valve dysfunction out to 10 years(Through Ten Years Post Procedure)
Investigators
Study Sites (1)
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