Implantation of the Venus P-Valve™ in the Pulmonic Position in Patients With Native Outflow Tracts

Venus MedTech

Status

Active, not recruiting

Conditions

Pulmonary Regurgitation

Treatments

Procedure: trans catheter heart valve replacement

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT02846753

VMT-001CE

Details and patient eligibility

About

A prospective, non-randomized multi-center clinical investigation of the Venus P-Valve™ for the treatment of pulmonary regurgitation with or without stenosis in patient with native outflow tracts.

Full description

This study evaluates the implantation of the Venus P-Valve™ for the treatment of patients with an incompetent pulmonic valve, which causes blood to flow back from the pulmonary artery into the right heart ventricle during pumping of the heart (pulmonary regurgitation). Patients with and without narrowing (stenosis) of the right ventricular outflow tract will be included. The purpose of this protocol is to assess the safety and performance of Venus P-Valve™ implantation.

Post-procedure, a clinical visit will be scheduled at 30 days, 6 month, 12 months, and annually thereafter to 3 years. Population: Patients≥12 years with a body weight of ≥30kg, with significant pulmonary regurgitation (≥3+) with or without right ventricular outflow tract (RVOT) stenosis (mean Doppler gradient ≥35mmHg) with native right ventricular outflow tracts.

Enrollment

84 patients

Sex

All

Ages

12 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Candidates for this study must meet all of the following Inclusion criteria:

Age: range from 12-70 years of age
Weight must be "equal to" or exceed 30 kilograms
Subject presents with evidence of moderate or severe (≥3+) pulmonary regurgitation by TTE
Subject presents with >30% pulmonary regurgitation fraction as defined by cardiac MRI
Subject is symptomatic from his/her pulmonary regurgitation or meets MRI criteria for intervention: right ventricular ejection fraction (RVEF) < 45%, pulmonary regurgitant fraction (PRRF) >30% and increased right ventricular end-diastolic volume (RVEDV) >150ml/m2
Subject will comply with specified follow-up evaluations, including echocardiograms and MRI
The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the ethics committee and regulatory authority if applicable of the respective clinical site
The subject and the treating physician agree that the subject will return for all required post-procedure follow up visits
Catheterization is determined to be feasible by the treating physician

Exclusion criteria

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

Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics)
Severe chest wall deformity
Leukopenia (WBC<3000 mm3)
Acute or chronic anemia (Hb <90g/l)
Platelet count <100,000 cells/mm3
In the judgment of the investigator, percutaneous introduction and delivery of the valve is not feasible
Need for emergency cardiac or vascular surgery, including pulmonary embolectomy, for any reason
Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
History of, or active, endocarditis, unless the endocarditis has been treated >6 months previous to the procedure
History of or current intravenous drug abuse
A known hypersensitivity to aspirin or heparin
Currently participating in an investigational drug or another device study [Note: Trials requiring extended follow up for products that were investigational, but have since become commercially available, are not considered investigational devices.]
Major or progressive non-cardiac disease resulting in a life expectancy of <1yr
Obstruction of the central veins preventing advancement of the pulmonary bioprosthesis delivery system to the heart
Positive urine or serum pregnancy test in female subjects of child-bearing potential
Ileofemoral vessel characteristics that would preclude safe placement of 19 French (F), 22 F and 24 F introducer sheath
Contraindication for cardiac magnetic resonance imaging or inability to cooperate with a cardiac magnetic resonance imaging exam
Need for concomitant interventional procedures