Clinical trial NCT02071654: Efficacy and Safety of Venus P-valve to Treat RVOT Stenosis With Pulmonary Regurgitation
Official title: Efficacy and Safety Evaluation of Transcatheter Pulmonary Valve Implantation for Right Ventricular Outflow Tract (RVOT) Stenosis After Congenital Heart Defect Surgical Correction Complicated With Severe Pulmonary Regurgitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Right Ventricular Outflow Tract Stenosis
Keywords: Venus P-valve
Lead sponsor: Venus MedTech (HangZhou) Inc.
Sponsor class: INDUSTRY
Collaborators: name: Core Medical (Beijing) Co., Ltd.
First posted: 2014-02-26
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement rate of RVEDV at 6 months post-procedure.
timeFrame: At 6 months post-implantation of Venus-P valve
Secondary outcomes:
measure: Safety Endpoints
timeFrame: From the date of implantation until 12 months post-procedure
Other outcomes:
measure: Feasibility and Performance Endpoints
timeFrame: Day 7 post-implantation
measure: Secondary Endpoints
timeFrame: From the date of valve implantation till 12 months post-procedure
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Junbo Ge, Prof., MD.
role: PRINCIPAL_INVESTIGATOR
References: