Efficacy and Safety of Venus P-valve to Treat RVOT Stenosis With Pulmonary Regurgitation

Venus MedTech

Status and phase: Unknown; Phase 3

Conditions: Right Ventricular Outflow Tract Stenosis

Treatments: Device: Venus P-valve transcatheter implantation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02071654

VEN2013-10/V2.0

Details and patient eligibility

About

A prospective, non-randomized, multi-center clinical study of the Venus P-valve for the treatment of RVOT stenosis with pulmonary regurgitation after surgery of congenital heart defect.

Full description

The aim of this protocol is to assess the efficacy, safety and performance of Venus P-valve.

Patients between 18-60 years with RVOT stenosis and moderate to severe pulmonary regurgitation (≥3+) who have undergone trans-annular patch repair of their RVOT, cardiac magnetic resonance (CMR) screening right ventricular end-diastolic volume index (RVEDVI) between 130-160mL/m2.

Post-procedure follow-ups will be scheduled at 24 hours, 30 days, 6 months and 12 months.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• RVOT stenosis who have undergone transannular patch repair with moderate to severe pulmonary regurgitation
• Isotopic or CMR criteria of RVEDVI≥130mL/m2 and ≤160mL/m2
• Age≥18 years and ≤60 years (Zhongshan Hospital age≥18 years and ≤60 years
• Body weight≥18 kg
• Pulmonary annular diameter between 14mm to 31mm
• RVOT length≥20mm
• The subject or his/her legal representative has provided written informed consent
• Subject will comply with protocol required follow-ups

Add any of the following conditions:

• Subject is symptomatic
• Subject presents with >30% pulmonary regurgitation fraction as defined by cardiac MRI
• ≥3+ pulmonary regurgitation by echocardiograms
• Deteriorating RVEF%
• Progressive tricuspid valve regurgitation (at least moderate degree)
• Complicated with RVOT obstruction (RV systolic pressure>80mmHg)
• Persistent arrhythmias

Exclusion criteria

Candidates will be excluded from the study if any of the following conditions are present:

• Existing pulmonary artery branch stenosis or artificial pulmonary valve
• Severe chest wall deformity
• ADHF
• Active infection or endocarditis requiring antibiotic therapy
• Leukopenia (WBC<3000mm3)
• Acute or chronic anemia (Hb<9g/L)
• Platelet account <100,000 cells/mm3
• In the judgment of the investigator, percutaneous introduction and delivery of the valve is not feasible
• A known hypersensitivity to aspirin or heparin
• Positive urine or serum pregnancy test in female subjects
• Ileofemoral vessel characteristics that would preclude safe placement of introducer sheath

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

Venus P-valve transcatheter implantation

Experimental group

Description:

Single arm of percutaneous implantation of Venus-P valve for treating RVOT stenosis

Treatment:

Device: Venus P-valve transcatheter implantation