Efficacy and Safety of Venus P-valve to Treat RVOT Stenosis With Pulmonary Regurgitation
Primary Purpose
Right Ventricular Outflow Tract Stenosis
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Venus P-valve transcatheter implantation
Sponsored by
About this trial
This is an interventional treatment trial for Right Ventricular Outflow Tract Stenosis focused on measuring Venus P-valve
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
Sites / Locations
- Zhongshan Hospital Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Venus P-valve transcatheter implantation
Arm Description
Single arm of percutaneous implantation of Venus-P valve for treating RVOT stenosis
Outcomes
Primary Outcome Measures
Improvement rate of RVEDV at 6 months post-procedure.
The improvement is defined as the RVEDVI≤108mL/m2 measured with CMR.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02071654
First Posted
January 11, 2014
Last Updated
January 3, 2015
Sponsor
Venus MedTech (HangZhou) Inc.
Collaborators
Core Medical (Beijing) Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02071654
Brief Title
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
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 2015 (Anticipated)
Study Completion Date
February 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Venus MedTech (HangZhou) Inc.
Collaborators
Core Medical (Beijing) Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Right Ventricular Outflow Tract Stenosis
Keywords
Venus P-valve
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Venus P-valve transcatheter implantation
Arm Type
Experimental
Arm Description
Single arm of percutaneous implantation of Venus-P valve for treating RVOT stenosis
Intervention Type
Device
Intervention Name(s)
Venus P-valve transcatheter implantation
Intervention Description
Percutaneous implantation of Venus-P valve to treat RVOT stenosis patients
Primary Outcome Measure Information:
Title
Improvement rate of RVEDV at 6 months post-procedure.
Description
The improvement is defined as the RVEDVI≤108mL/m2 measured with CMR.
Time Frame
At 6 months post-implantation of Venus-P valve
Secondary Outcome Measure Information:
Title
Safety Endpoints
Description
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.
Time Frame
From the date of implantation until 12 months post-procedure
Other Pre-specified Outcome Measures:
Title
Feasibility and Performance Endpoints
Description
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. )
Time Frame
Day 7 post-implantation
Title
Secondary Endpoints
Description
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
Time Frame
From the date of valve implantation till 12 months post-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Liu, MD
Phone
+86 10 6595 6828
Ext
806
Email
davidliu@coremed.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junbo Ge, Prof., MD.
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Liu, MD
Phone
+86 10 6595 6828
Ext
806
Email
davidliu@coremed.com.cn
First Name & Middle Initial & Last Name & Degree
Daxin Zhou, MD
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Venus P-valve to Treat RVOT Stenosis With Pulmonary Regurgitation
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