Implantation of the Venus P-Valve™ in the Pulmonic Position in Patients With Native Outflow Tracts
Primary Purpose
Pulmonary Regurgitation
Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
trans catheter heart valve replacement
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Regurgitation
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Implantation of Venus P-Valve™
Arm Description
Implantation of the Venus P-Valve™ in the pulmonic position in patients with native outflow tracts; trans catheter heart valve replacement.
Outcomes
Primary Outcome Measures
Safety of Venus P-Valve™ measured as probability of death/reoperation
Occurrence of death or reoperation (Valve and/or procedure related) calculated as a composite freedom-of-death and -reoperation probability at 12 months. The acceptance criterion for mortality and reoperation is 16% (or equivalently 84% freedom from death and reoperation). If the lower 95% confidence limit for survival and freedom from reoperation at 12 months is greater than 84%, the acceptance criterion for safety will have been met.
Safety of Venus P-Valve™ measured as probability of Major Adverse Cardiac and Cerebro-vascular Event (MACCE)
Occurrence of MACCE (defined as death, myocardial infarction, reoperation, vascular injury resulting in the need for an unplanned vascular grafting intervention, stroke, and pulmonary embolism) calculated as freedom-from-MACCE probability at month-1, calculated using the Kaplan Meier method
Performance of Venus P-Valve™ measured as Success rate of valve placement and implantation
The device success is defined as the percentage of subjects with successful implant of the P-Valve assessed at the earliest evaluable echocardiogram. Linearized rates will be presented.
Hemodynamic Performance of Venus P-Valve™ measured as the mean transvalvular pressure (mmHg)
Hemodynamic performance, measured as the mean transvalvular pressure gradient measured by transthoracic echocardiogram at month-1
Performance of Venus P-Valve™ measured as change of pulmonary regurgitation (regurgitation classification by MRI)
Improvement or abolition of pulmonary regurgitation assessed by MRI at baseline and month 6, with grading of pulmonary stenosis defined as: mild <2, moderate: 2-4; severe >4
Performance of Venus P-Valve™ measured as change of pulmonary regurgitation (regurgitation classification by transthoracic echocardiogram)
Improvement or abolition of pulmonary regurgitation assessed by transthoracic echocardiogram at baseline, day 1, month 1, 6, 12 and annually thereafter to 3 years post procedure, with grading of pulmonary stenosis defined as: mild <2, moderate: 2-4; severe >4
Performance of Venus P-Valve™ measured as percentage of subjects with structural valve deterioration
Structural valve deterioration assessment includes stent fracture, leaflet mobility, thickening and calcification
Secondary Outcome Measures
Safety measured as percentage of subjects experiencing serious adverse events
Within the duration of the study of the percentage of patients experiencing the following events is measured:
Device migration/embolization
Valvar thrombosis
Thromboembolism
Bleeding
Paravalvar leak
Endocarditis
Nonstructural dysfunction
Explant
Hemolysis
Arrhythmias
all other serious adverse events as defined in protocol section 6.2
Functional improvement measured as decreased pulmonary regurgitation (regurgitation classification by transthoracic echocardiogram )
Improved valve function demonstrated by a decrease in pulmonary regurgitation (PR) to mild or less (≤ 2) by transthoracic echocardiogram (TTE) at month-1
Functional improvement measured as decreased pulmonary regurgitation (regurgitation classification by MRI)
Improved valve function demonstrated by a decrease in pulmonary regurgitation (PR) to mild or less (≤ 2) by MRI at month-6
Full Information
NCT ID
NCT02846753
First Posted
May 3, 2016
Last Updated
April 18, 2023
Sponsor
Venus MedTech (HangZhou) Inc.
Collaborators
IQVIA Inc., TheraGenesis, Intrials
1. Study Identification
Unique Protocol Identification Number
NCT02846753
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 17, 2016 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Venus MedTech (HangZhou) Inc.
Collaborators
IQVIA Inc., TheraGenesis, Intrials
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Regurgitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Implantation of Venus P-Valve™
Arm Type
Experimental
Arm Description
Implantation of the Venus P-Valve™ in the pulmonic position in patients with native outflow tracts; trans catheter heart valve replacement.
Intervention Type
Procedure
Intervention Name(s)
trans catheter heart valve replacement
Intervention Description
trans catheter heart valve replacement
Primary Outcome Measure Information:
Title
Safety of Venus P-Valve™ measured as probability of death/reoperation
Description
Occurrence of death or reoperation (Valve and/or procedure related) calculated as a composite freedom-of-death and -reoperation probability at 12 months. The acceptance criterion for mortality and reoperation is 16% (or equivalently 84% freedom from death and reoperation). If the lower 95% confidence limit for survival and freedom from reoperation at 12 months is greater than 84%, the acceptance criterion for safety will have been met.
Time Frame
month 12 follow-up
Title
Safety of Venus P-Valve™ measured as probability of Major Adverse Cardiac and Cerebro-vascular Event (MACCE)
Description
Occurrence of MACCE (defined as death, myocardial infarction, reoperation, vascular injury resulting in the need for an unplanned vascular grafting intervention, stroke, and pulmonary embolism) calculated as freedom-from-MACCE probability at month-1, calculated using the Kaplan Meier method
Time Frame
month 1 follow-up
Title
Performance of Venus P-Valve™ measured as Success rate of valve placement and implantation
Description
The device success is defined as the percentage of subjects with successful implant of the P-Valve assessed at the earliest evaluable echocardiogram. Linearized rates will be presented.
Time Frame
up to 30 days
Title
Hemodynamic Performance of Venus P-Valve™ measured as the mean transvalvular pressure (mmHg)
Description
Hemodynamic performance, measured as the mean transvalvular pressure gradient measured by transthoracic echocardiogram at month-1
Time Frame
1 month
Title
Performance of Venus P-Valve™ measured as change of pulmonary regurgitation (regurgitation classification by MRI)
Description
Improvement or abolition of pulmonary regurgitation assessed by MRI at baseline and month 6, with grading of pulmonary stenosis defined as: mild <2, moderate: 2-4; severe >4
Time Frame
baseline and month 6
Title
Performance of Venus P-Valve™ measured as change of pulmonary regurgitation (regurgitation classification by transthoracic echocardiogram)
Description
Improvement or abolition of pulmonary regurgitation assessed by transthoracic echocardiogram at baseline, day 1, month 1, 6, 12 and annually thereafter to 3 years post procedure, with grading of pulmonary stenosis defined as: mild <2, moderate: 2-4; severe >4
Time Frame
baseline, day 1, month 1, 6, 12 and annually thereafter to 3 years post procedure
Title
Performance of Venus P-Valve™ measured as percentage of subjects with structural valve deterioration
Description
Structural valve deterioration assessment includes stent fracture, leaflet mobility, thickening and calcification
Time Frame
month 6
Secondary Outcome Measure Information:
Title
Safety measured as percentage of subjects experiencing serious adverse events
Description
Within the duration of the study of the percentage of patients experiencing the following events is measured:
Device migration/embolization
Valvar thrombosis
Thromboembolism
Bleeding
Paravalvar leak
Endocarditis
Nonstructural dysfunction
Explant
Hemolysis
Arrhythmias
all other serious adverse events as defined in protocol section 6.2
Time Frame
up to third year of follow-up
Title
Functional improvement measured as decreased pulmonary regurgitation (regurgitation classification by transthoracic echocardiogram )
Description
Improved valve function demonstrated by a decrease in pulmonary regurgitation (PR) to mild or less (≤ 2) by transthoracic echocardiogram (TTE) at month-1
Time Frame
1 month
Title
Functional improvement measured as decreased pulmonary regurgitation (regurgitation classification by MRI)
Description
Improved valve function demonstrated by a decrease in pulmonary regurgitation (PR) to mild or less (≤ 2) by MRI at month-6
Time Frame
month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shakeel A. Qureshi, MD
Organizational Affiliation
Evelina Children's Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The results of the study will be reported and disseminated in peer-reviewed scientific journals, internal reports, conference presentations and submissions to regulatory authorities. Nevertheless, all data used in the analysis and reporting of this clinical investigation will be without identifiable reference to individual patients. All the data will be anonymous.
Learn more about this trial
Implantation of the Venus P-Valve™ in the Pulmonic Position in Patients With Native Outflow Tracts
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