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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
Venus MedTech (HangZhou) Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Regurgitation

Eligibility Criteria

12 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 3, 2016
    Last Updated
    April 18, 2023
    Sponsor
    Venus MedTech (HangZhou) Inc.
    Collaborators
    IQVIA Inc., TheraGenesis, Intrials
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    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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