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

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

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.

Study Overview

• Status: Unknown
• Conditions: Right Ventricular Outflow Tract Stenosis
• Intervention / Treatment: Device: Venus P-valve transcatheter implantation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital Fudan University
      • Principal Investigator: Daxin Zhou, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Venus P-valve transcatheter implantation; Single arm of percutaneous implantation of Venus-P valve for treating RVOT stenosis	Device: Venus P-valve transcatheter implantation; Percutaneous implantation of Venus-P valve to treat RVOT stenosis patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement rate of RVEDV at 6 months post-procedure.	The improvement is defined as the RVEDVI≤108mL/m2 measured with CMR.	At 6 months post-implantation of Venus-P valve

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoints	Accumulated occurrences (rate of patients/year) of procedure-related clinical events (death, severe arrhythmias, cardiac tamponade, RVOT or pulmonary artery perforation or rupture, cardiac shock, endocarditis from the date of valve implantation up to 12 months post-procedure or bleeding due to use of heparin/aspirin at 48 hours post-procedure assessed per protocol. Occurrence of all deaths (cardiac death, non-cardiac deaths and other deaths) and stroke one year post-procedure.	From the date of implantation until 12 months post-procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility and Performance Endpoints	Immediate success of implantation of the device measured in percentage (placement of the device and functional stability measured with angiography and hemodynamic performance). Function normal of the P valve measured in percentage without major adverse events at day 7. (Function normal defined as the P valve's position and function are normal through exams of electrocardiography (EKG), transthoracic echocardiogram (TTE), chest X-ray. )	Day 7 post-implantation
Secondary Endpoints	Changes of images and clinical parameters pre- and post-procedure at 12 months.; CMR: right ventricular volume (expressed as ml/m2), RV ejection fraction (expressed as percentage), pulmonary regurgitation (functional classification as grade I, IIa, IIb and III).; Echo: device position(expressed as percentage), hemodynamic performance of velocity of RVOT and pulmonary valve (expressed as m/s), transvalvular pressure gradient, peak pulmonary valve gradient, mean gradient (expressed as the difference of pressure in mmHg.); NYHA class	From the date of valve implantation till 12 months post-procedure

Collaborators and Investigators

• Sponsor: Venus MedTech (HangZhou) Inc.
• Collaborators: Core Medical (Beijing) Co., Ltd.
• Investigators: Principal Investigator: Junbo Ge, Prof., MD., Fudan University

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Anticipated): February 1, 2015
• Study Completion (Anticipated): February 1, 2016

Study Registration Dates

• First Submitted: January 11, 2014
• First Submitted That Met QC Criteria: February 21, 2014
• First Posted (Estimate): February 26, 2014

Study Record Updates

• Last Update Posted (Estimate): January 6, 2015
• Last Update Submitted That Met QC Criteria: January 3, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Venus P-valve
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Valve Diseases; Constriction, Pathologic; Pulmonary Valve Insufficiency
• Other Study ID Numbers: VEN2013-10/V2.0