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VenusP-Valve Pivotal Study (PROTEUS STUDY) (PROTEUS)

Primary Purpose

Pulmonary Regurgitation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transcatheter pulmonary valve implantation (TPVI)
VenusP-ValveTM System
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 - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Weight ≥25kg (55 lbs.) Age ≥ 12 years olds Patients have a dysfunctional native RVOT with severe pulmonary regurgitation (i.e., severe pulmonary regurgitation as determined by echocardiography or pulmonary regurgitant fraction ≥30% as determined by cardiac magnetic resonance imaging) and without significant pulmonary stenosis (significant pulmonary stenosis is defined as gradient more than 25mmHg) and are clinically indicated for intervention: 1) For symptomatic patients, fitting the following criteria: Severe pulmonary regurgitation measured by echocardiogram or pulmonary regurgitant fraction ≥30% measured by CMR 2) For asymptomatic patients, including any 2 of the following criteria: Mild or moderate RV or LV systolic dysfunction. Severe RV dilation (RVEDVI ≥145 mL/m2 or RVESVI ≥ 75 mL/m2or RVEDV >2 × LVEDV). Progressive reduction in objective exercise tolerance. 4. Patient is willing to consent to participate in the study and will commit to completion of all follow-up requirements. Exclusion Criteria: Clinical or biological signs of infection including active endocarditis. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation. Leukopenia, anemia, thrombocytopenia, or any known blood clotting disorder, deemed clinically significant after consultation with Haemato-oncology specialists. Inappropriate anatomy for femoral or right internal jugular vein (RIJ) introduction and delivery of the VenusP-ValveTM System. RVOT anatomy or morphology that is unfavorable for device anchoring. Anatomy unable to accommodate VenusP-Valve delivery system. Angiographic evidence of coronary artery compression that would result from transcatheter pulmonary valve replacement (TPVR). Emergency interventional/surgical procedures within 30 days prior to the index procedure. Planned significant and relevant concomitant procedure at time of VenusP-Valve implant. Any planned interventional/surgical procedures to be performed within the 30 days follow-up from VenusP-Valve implant. Known history of intravenous drug abuse in the past 5 years, without certificate of completion of rehabilitation from a specialist. Major or progressive non-cardiac disease resulting in a life expectancy of less than one year. Known hypersensitivity or contraindication to antiplatelet, antithrombotic medications, or nitinol (titanium or nickel) leading to be unable to undergo index procedure per physicians' judgement Positive pregnancy test at baseline (prior to CT angiography and again prior to implant procedure) in female patients of child-bearing potential. Currently participating in an investigational drug or another device study. Patient or guardian unwilling or unable to provide written informed consent or comply with follow-up requirements. The investigators consider that the patients are not suitable to participate in this research.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    TPVI

    Arm Description

    Outcomes

    Primary Outcome Measures

    The rate of procedure or device related mortality at the 30 days follow-up visit post procedure
    Freedom from procedure or device related mortality at 30 days
    The rate of re-intervention and acceptable hemodynamic function at 6 Month follow-up visit post procedure
    Freedom from VenusP-Valve re-intervention and acceptable hemodynamic function at 6 months defined as: No more than mild regurgitation measured by CMR; AND Mean RVOT gradient as measured by echocardiography ≤35mmHg.

    Secondary Outcome Measures

    The rate of all-cause mortality, procedure or device related mortality, and procedure or device related Major Adverse Cardiac and Cerebrovascular Events (MACCE) out to 10 years
    Freedom from all-cause mortality, procedure or device related mortality out to 10 years Freedom from procedure or device related Major Adverse Cardiac and Cerebrovascular Events (MACCE) out to 10 years MACCE is defined as a non-hierarchic composite including the following procedure or device related events: 1) Stroke 2) RVOT reintervention 3) Arrhythmia 4) Coronary artery compression requiring intervention or causing myocardial infarction 5) Device-related endocarditis 6) Major stent fracture 7) Valve thrombosis 8) Valve embolization or significant malposition 9) Major vascular or access complications* 10) Pulmonary embolism
    The rate of technical Success during the procedure
    Technical success at exit from catheterization lab or operating room Defined as a composite of: Freedom from procedure or device related mortality Successful access, delivery of the device, and retrieval of the delivery system Correct positioning of the valve(s) into the proper anatomical location Freedom from reintervention related to the device or to a major vascular or access-related, or cardiac structural complications
    The rate of acceptable hemodynamic performance at 30 days, 1-5 years, 7 years and 10 years.
    Acceptable hemodynamic performance at 30 days, 1-5 years, 7 years and 10 years. Defined as: Mean RVOT gradient ≤ 35mmHg AND, No more than mild regurgitation measured by echocardiography
    The rate of procedure success out to 30 days
    Procedure success out to 30 days, defined as follows: Device success at 30 days. Defined as a composite of: Freedom from procedure or device related mortality Original intended device in place No additional surgical or interventional procedures related to the procedure or the device since completion of the index procedure Hemodynamic performance: relief of insufficiency (mild or less pulmonary regurgitation) without producing the opposite (mean RVOT gradient > 35 mmHg) as measured by echocardiography No new ventricular arrhythmia requiring ICD implantation None of the following procedure or device related serious adverse events: Life-threatening major bleeding Major vascular or cardiac structural complications requiring unplanned reintervention or surgery Stage 2 or 3 acute kidney injury (AKI) includes new dialysis Pulmonary embolism Severe heart failure or hypotension requiring intravenous inotrope
    The rate of valve dysfunction out to 10 years
    Freedom from valve dysfunction out to 10 years Defined as a composite of: RVOT re-intervention for device-related reasons Hemodynamic dysfunction of the valve (moderate or greater pulmonary regurgitation, and/or a mean RVOT gradient > 35 mmHg)
    New York Heart Association (NYHA) classification Through out to 10 years
    Functional status (New York Heart Association (NYHA) classification) out to 10 years
    Characterization of quality-of-life scores out to 5 year, and at 10 years
    Characterization of quality-of-life scores out to 5 year, and at 10 years As assessed by the SF-36-QOL.

    Full Information

    First Posted
    August 10, 2023
    Last Updated
    August 28, 2023
    Sponsor
    Venus MedTech (HangZhou) Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06010563
    Brief Title
    VenusP-Valve Pivotal Study (PROTEUS STUDY)
    Acronym
    PROTEUS
    Official Title
    Evaluation of the Performance Of The VenusP-ValveTM System in Patients With Native RVOT Dysfunction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2024 (Anticipated)
    Study Completion Date
    August 30, 2034 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Venus MedTech (HangZhou) Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A prospective, multi-center, non-randomized interventional study to evaluate the safety and effectiveness of the VenusP-ValveTM System in patients with native right ventricular outflow tract (RVOT) dysfunction. Post procedure, a clinical visit will be scheduled at pre-discharge, 30 days, 6 months, 12 months, and annually thereafter to 10 years. About 60 subjects will be enrolled in this study. Data analysis will be performed after all enrolled subjects complete 6-month follow-up and the primary endpoint analysis report will be submitted to FDA for PMA approval.

    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
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TPVI
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Transcatheter pulmonary valve implantation (TPVI)
    Intervention Description
    A valve is implanted through a catheter (a narrow tube) and inserted through the femoral vein into the right atrium, right ventricle and pulmonary artery. After careful positioning, the valve is implanted by inflating a set of a balloons on the delivery catheter or self-expanding. After the catheter has been removed, the incision is closed with stitches, which are removed after the area has healed.
    Intervention Type
    Device
    Intervention Name(s)
    VenusP-ValveTM System
    Intervention Description
    VenusP-ValveTM System consists of two components: Transcatheter Pulmonary Valve (TPV) Delivery System (DS) including Delivery Catheter System (DCS) and Compression Loading System (CLS) The TPV consists of a self-expanding nitinol stent with a single layer tri-leaflet porcine pericardium tissue. For the Delivery Catheter System (DCS) , the distal (deployment) end of the system features an atraumatic, radiopaque tip. A protective sheath (capsule) covers and maintains the TPV in a crimped position. The handle at the proximal end of the catheter is used to load and deploy the TPV. The CLS compresses the TPV into the catheter, which including capture tube, valve protection tube, tip support tube, loading mandrels and crimper.
    Primary Outcome Measure Information:
    Title
    The rate of procedure or device related mortality at the 30 days follow-up visit post procedure
    Description
    Freedom from procedure or device related mortality at 30 days
    Time Frame
    At 30 Days Post Procedure
    Title
    The rate of re-intervention and acceptable hemodynamic function at 6 Month follow-up visit post procedure
    Description
    Freedom from VenusP-Valve re-intervention and acceptable hemodynamic function at 6 months defined as: No more than mild regurgitation measured by CMR; AND Mean RVOT gradient as measured by echocardiography ≤35mmHg.
    Time Frame
    At 6 Months Post Procedure
    Secondary Outcome Measure Information:
    Title
    The rate of all-cause mortality, procedure or device related mortality, and procedure or device related Major Adverse Cardiac and Cerebrovascular Events (MACCE) out to 10 years
    Description
    Freedom from all-cause mortality, procedure or device related mortality out to 10 years Freedom from procedure or device related Major Adverse Cardiac and Cerebrovascular Events (MACCE) out to 10 years MACCE is defined as a non-hierarchic composite including the following procedure or device related events: 1) Stroke 2) RVOT reintervention 3) Arrhythmia 4) Coronary artery compression requiring intervention or causing myocardial infarction 5) Device-related endocarditis 6) Major stent fracture 7) Valve thrombosis 8) Valve embolization or significant malposition 9) Major vascular or access complications* 10) Pulmonary embolism
    Time Frame
    Through Ten Years Post Procedure
    Title
    The rate of technical Success during the procedure
    Description
    Technical success at exit from catheterization lab or operating room Defined as a composite of: Freedom from procedure or device related mortality Successful access, delivery of the device, and retrieval of the delivery system Correct positioning of the valve(s) into the proper anatomical location Freedom from reintervention related to the device or to a major vascular or access-related, or cardiac structural complications
    Time Frame
    During the Procedure
    Title
    The rate of acceptable hemodynamic performance at 30 days, 1-5 years, 7 years and 10 years.
    Description
    Acceptable hemodynamic performance at 30 days, 1-5 years, 7 years and 10 years. Defined as: Mean RVOT gradient ≤ 35mmHg AND, No more than mild regurgitation measured by echocardiography
    Time Frame
    At 30 Days, 1-5 Years, 7 Years and 10 Years Post Procedure
    Title
    The rate of procedure success out to 30 days
    Description
    Procedure success out to 30 days, defined as follows: Device success at 30 days. Defined as a composite of: Freedom from procedure or device related mortality Original intended device in place No additional surgical or interventional procedures related to the procedure or the device since completion of the index procedure Hemodynamic performance: relief of insufficiency (mild or less pulmonary regurgitation) without producing the opposite (mean RVOT gradient > 35 mmHg) as measured by echocardiography No new ventricular arrhythmia requiring ICD implantation None of the following procedure or device related serious adverse events: Life-threatening major bleeding Major vascular or cardiac structural complications requiring unplanned reintervention or surgery Stage 2 or 3 acute kidney injury (AKI) includes new dialysis Pulmonary embolism Severe heart failure or hypotension requiring intravenous inotrope
    Time Frame
    At 30 Days Post Procedure
    Title
    The rate of valve dysfunction out to 10 years
    Description
    Freedom from valve dysfunction out to 10 years Defined as a composite of: RVOT re-intervention for device-related reasons Hemodynamic dysfunction of the valve (moderate or greater pulmonary regurgitation, and/or a mean RVOT gradient > 35 mmHg)
    Time Frame
    Through Ten Years Post Procedure
    Title
    New York Heart Association (NYHA) classification Through out to 10 years
    Description
    Functional status (New York Heart Association (NYHA) classification) out to 10 years
    Time Frame
    Through Ten Years Post Procedure
    Title
    Characterization of quality-of-life scores out to 5 year, and at 10 years
    Description
    Characterization of quality-of-life scores out to 5 year, and at 10 years As assessed by the SF-36-QOL.
    Time Frame
    Through Five Years Post Procedure, and at 10 Years Post Procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Weight ≥25kg (55 lbs.) Age ≥ 12 years olds Patients have a dysfunctional native RVOT with severe pulmonary regurgitation (i.e., severe pulmonary regurgitation as determined by echocardiography or pulmonary regurgitant fraction ≥30% as determined by cardiac magnetic resonance imaging) and without significant pulmonary stenosis (significant pulmonary stenosis is defined as gradient more than 25mmHg) and are clinically indicated for intervention: 1) For symptomatic patients, fitting the following criteria: Severe pulmonary regurgitation measured by echocardiogram or pulmonary regurgitant fraction ≥30% measured by CMR 2) For asymptomatic patients, including any 2 of the following criteria: Mild or moderate RV or LV systolic dysfunction. Severe RV dilation (RVEDVI ≥145 mL/m2 or RVESVI ≥ 75 mL/m2or RVEDV >2 × LVEDV). Progressive reduction in objective exercise tolerance. 4. Patient is willing to consent to participate in the study and will commit to completion of all follow-up requirements. Exclusion Criteria: Clinical or biological signs of infection including active endocarditis. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation. Leukopenia, anemia, thrombocytopenia, or any known blood clotting disorder, deemed clinically significant after consultation with Haemato-oncology specialists. Inappropriate anatomy for femoral or right internal jugular vein (RIJ) introduction and delivery of the VenusP-ValveTM System. RVOT anatomy or morphology that is unfavorable for device anchoring. Anatomy unable to accommodate VenusP-Valve delivery system. Angiographic evidence of coronary artery compression that would result from transcatheter pulmonary valve replacement (TPVR). Emergency interventional/surgical procedures within 30 days prior to the index procedure. Planned significant and relevant concomitant procedure at time of VenusP-Valve implant. Any planned interventional/surgical procedures to be performed within the 30 days follow-up from VenusP-Valve implant. Known history of intravenous drug abuse in the past 5 years, without certificate of completion of rehabilitation from a specialist. Major or progressive non-cardiac disease resulting in a life expectancy of less than one year. Known hypersensitivity or contraindication to antiplatelet, antithrombotic medications, or nitinol (titanium or nickel) leading to be unable to undergo index procedure per physicians' judgement Positive pregnancy test at baseline (prior to CT angiography and again prior to implant procedure) in female patients of child-bearing potential. Currently participating in an investigational drug or another device study. Patient or guardian unwilling or unable to provide written informed consent or comply with follow-up requirements. The investigators consider that the patients are not suitable to participate in this research.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cong Ma
    Phone
    +8618817939751
    Email
    macong@venusmedtech.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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