Clinical trial NCT02846753: Implantation of the Venus P-Valve™ in the Pulmonic Position in Patients With Native Outflow Tracts
Official title: Implantation of the Venus P-Valve™ in the Pulmonic Position in Patients With Native Outflow Tracts
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Regurgitation
Lead sponsor: Venus MedTech (HangZhou) Inc.
Sponsor class: INDUSTRY
Collaborators: name: IQVIA Inc.
name: TheraGenesis
name: Intrials
First posted: 2016-07-27
Enrollment: 84
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety of Venus P-Valve™ measured as probability of death/reoperation
timeFrame: month 12 follow-up
measure: Safety of Venus P-Valve™ measured as probability of Major Adverse Cardiac and Cerebro-vascular Event (MACCE)
timeFrame: month 1 follow-up
measure: Performance of Venus P-Valve™ measured as Success rate of valve placement and implantation
timeFrame: up to 30 days
measure: Hemodynamic Performance of Venus P-Valve™ measured as the mean transvalvular pressure (mmHg)
timeFrame: 1 month
measure: Performance of Venus P-Valve™ measured as change of pulmonary regurgitation (regurgitation classification by MRI)
timeFrame: baseline and month 6
measure: Performance of Venus P-Valve™ measured as change of pulmonary regurgitation (regurgitation classification by transthoracic echocardiogram)
timeFrame: baseline, day 1, month 1, 6, 12 and annually thereafter to 3 years post procedure
measure: Performance of Venus P-Valve™ measured as percentage of subjects with structural valve deterioration
timeFrame: month 6
Secondary outcomes:
measure: Safety measured as percentage of subjects experiencing serious adverse events
timeFrame: up to third year of follow-up
measure: Functional improvement measured as decreased pulmonary regurgitation (regurgitation classification by transthoracic echocardiogram )
timeFrame: 1 month
measure: Functional improvement measured as decreased pulmonary regurgitation (regurgitation classification by MRI)
timeFrame: month 6
Other outcomes:
Locations:
Study officials:
affiliation: Evelina Children's Hospital
name: Shakeel A. Qureshi, MD
role: PRINCIPAL_INVESTIGATOR
References: