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 enrollmentJune 11, 2024

ConditionsPulmonary Regurgitation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pulmonary Regurgitation
Sponsor: Venus MedTech (HangZhou) Inc.
Enrollment: 60
Locations: 1
Primary Endpoint: The rate of procedure or device related mortality at the 30 days follow-up visit post procedure
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

June 11, 2024

End Date

August 30, 2034

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Venus MedTech (HangZhou) Inc.

Responsible Party

Sponsor

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:
•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.

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 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 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 valve dysfunction out to 10 years(Through Ten Years Post Procedure)
The rate of technical Success during the procedure(During the Procedure)