search
Back to results

Venus-Vitae Pivotal Study Smart-Align Study

Primary Purpose

Aortic Valve Stenosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Venus-Vitae Transcatheter Heart Valve System
Sponsored by
Venus MedTech (HangZhou) Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 18 years Patients with the symptoms of severe aortic stenosis Severe aortic stenosis (AS, grade 3+), defined as AVA ≤ 1 cm2 (AVAi ≤ 0.6 cm2/m3) or Vmax ≥ 4.0 m/s or MPG ≥ 40 mmHg determined by echocardiography Patients deemed for cardiac intervention by a heart team Patients of all surgical risk categories can be enrolled in this study, but should follows local medical practices and regulatories. Patients or their legal reprensentatives are willing to participate in the study and provide written informed consent, and agree to follow the follow-up requirements Exclusion Criteria: A subject meeting any of the following criteria shall be excluded: Co-morbidities Previous mechanical or biological aortic valve replacement Untreated mitral, tricuspid or pulmonary valve diseases requiring procedural intervention Acute myocardial infact within 30 days prior to index procedure Untreated clinical significant coronary artery disease requiring revascularization Any therapeutic invasive cardiac procedure performed within 30 days (or drug-eluting coronary stent/scaffold implant within 6 months) Sever symptomatic carotid artery stenosis Stroke or TIA within 3 months or Modified Rankin Scale ≥ 4 disability Chronic kidney disease (eGFR<30 mL/min/1.73m2) Haemotologic disorders: Leukopenia (WBC < 3000 cell/mL), anemia (Hgb < 9 g/dL), thrombocytopenia (Plt< 50,000 cell/mL), or any known blood clotting disorder, deemed clinically significant after consultation with Haematooncology specialists Severe right heart dysfunction Anatomical LVEF < 20% Echocardiographic evidence of intracardiac mass, thrombus, or vegetation Inappropriate anatomy for femoral introduction and delivery of study device Native aortic valve geometry and size unfavorable for study device anchoring General Haemodynamics instability requiring inotropic support or intra-aortic balloon pump (IABP) or other hemodynamic support device, or any mechanical heart assistance Known hypersensitivity or contraindication to antiplatelet, antithrombotic medications, or cobalt-chromium leading to be unable to undergo index procedure per physicians' judgement Life expectancy ≤ 1 year due to noncardiac reasons Active infection requiring antibiotic therapy including infective endocarditis Planned relevant concomitant procedure within 30 days post index procedure Pregnant, breastfeeding or intend to become pregnant within 1 year

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    procedure

    Arm Description

    implant valve by TAVR

    Outcomes

    Primary Outcome Measures

    The rate of deaths at the one-year follow-up visit post procedure
    All-cause mortality (The rate of deaths at the one-year follow-up visit post procedure)
    Acceptable Hemodynamic Performance at 30 days
    Acceptable Bio-prosthesis Hemodynamic Performance at 30 days, defined as: Mean gradient < 20mmHg Less than moderate aortic regurgitation (perivalvular and transvalvular)

    Secondary Outcome Measures

    Occurrence of the following adverse events echocardiogram during follow-up
    Occurrence of the following adverse events echocardiogram during follow-up (The rate of follow events during the follow-up) All-cause mortality All stroke Life-threatening bleeding Acute MI Heart failure hospitalizations New permanent pacemaker implantation Major vascular complication Acute kidney injury Aortic valve re-intervention (surgical or transcatheter) Valve thrombosis Structural valve deterioration
    Technical success is defined as the following
    Technical success (at exit from procedure room) (VARC-3[1]) (The rate of Technical success at the Procedure) Freedom from mortality Successful access, delivery of the device, and retrieval of the delivery system Correct positioning of a single prosthetic heart valve into the proper anatomical location Freedom from surgery or intervention related to the device or a major vascular or access-related, or cardiac structural complication
    The rate of device success is defined as the following
    Device success (in-hospital) (VARC-3[1]) (The rate of device success during the in-hospital) Freedom from mortality Freedom from surgery or intervention related to the device or a major vascular or access-related or cardiac structural complication Intended performance of the valve (mean gradient < 20 mmHg, peak velocity <3 m/s, and less than moderate aortic regurgitation)
    The rate of acceptable valve function at pre-discharge by echocardiogram defined as the following:
    Acceptable valve function at pre-discharge by echocardiogram (The rate of follow events during the follow-up) Freedom from moderate or greater patient-prosthesis mismatch (PPM) MPG <20mmHg Freedom from moderate or greater regurgitation (transvalvular and paravalvular) Freedom from reoperation or intervention
    The rate of freedom from severe coronary overlap assessed by post-implant angiogram
    Freedom from severe coronary overlap assessed by post-implant angiogram
    The rate of freedom from mild or greater commissure misalignment assessed by post-implant angiogram and/or 30-day CT
    Freedom from mild or greater commissure misalignment assessed by post-implant angiogram and/or 30-day CT (post-implant 30-day CT scan is not mandatory for each subjects)
    The rate of freedom from mild or greater PVL by echocardiogram during follow-up
    Freedom from mild or greater PVL by echocardiogram during follow-up
    New York Heart Association (NYHA) classification during follow-up
    New York Heart Association (NYHA) classification during follow-up

    Full Information

    First Posted
    June 26, 2023
    Last Updated
    August 14, 2023
    Sponsor
    Venus MedTech (HangZhou) Inc.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05991271
    Brief Title
    Venus-Vitae Pivotal Study Smart-Align Study
    Official Title
    Multicenter Pivotal Study to Evaluate the Treatment of Severe Aortic Valve Stenosis With Next-Generation Venus-Vitae Transcatheter Heart Valve (THV) System
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 31, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    June 30, 2029 (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
    No

    5. Study Description

    Brief Summary
    The purpose is to evaluate the safety, effectiveness and performance of Venus-Vitae Transcatheter Heart Valve System in patients with severe aortic stenosis.
    Detailed Description
    This trial is a prospective, multi-center, non-randomized interventional study to evaluate the safety, effectiveness and performance of the Venus-Vitae Transcatheter Heart Valve System in patients with severe aortic stenosis. Clinical visits will be scheduled at screening, pre-discharge, 30 days, 6 months, 12 months and annually thereafter to 5 years.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aortic Valve Stenosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    procedure
    Arm Type
    Experimental
    Arm Description
    implant valve by TAVR
    Intervention Type
    Device
    Intervention Name(s)
    Venus-Vitae Transcatheter Heart Valve System
    Intervention Description
    The Venus-Vitae THV is comprised of balloon-expandable and radiopaque cobalt-chromium alloy frame, porcine pericardium tri-leaflet, porcine pericardium inner skirt, polyurethane outer skirt, PTFE assembly sutures, and three radiopaque gold markers (Figure 1). The valve utilizes Venus Endura technology and stored in a non-aqueous condition.
    Primary Outcome Measure Information:
    Title
    The rate of deaths at the one-year follow-up visit post procedure
    Description
    All-cause mortality (The rate of deaths at the one-year follow-up visit post procedure)
    Time Frame
    1 Years
    Title
    Acceptable Hemodynamic Performance at 30 days
    Description
    Acceptable Bio-prosthesis Hemodynamic Performance at 30 days, defined as: Mean gradient < 20mmHg Less than moderate aortic regurgitation (perivalvular and transvalvular)
    Time Frame
    30 Days
    Secondary Outcome Measure Information:
    Title
    Occurrence of the following adverse events echocardiogram during follow-up
    Description
    Occurrence of the following adverse events echocardiogram during follow-up (The rate of follow events during the follow-up) All-cause mortality All stroke Life-threatening bleeding Acute MI Heart failure hospitalizations New permanent pacemaker implantation Major vascular complication Acute kidney injury Aortic valve re-intervention (surgical or transcatheter) Valve thrombosis Structural valve deterioration
    Time Frame
    5 Years
    Title
    Technical success is defined as the following
    Description
    Technical success (at exit from procedure room) (VARC-3[1]) (The rate of Technical success at the Procedure) Freedom from mortality Successful access, delivery of the device, and retrieval of the delivery system Correct positioning of a single prosthetic heart valve into the proper anatomical location Freedom from surgery or intervention related to the device or a major vascular or access-related, or cardiac structural complication
    Time Frame
    During the Procedure
    Title
    The rate of device success is defined as the following
    Description
    Device success (in-hospital) (VARC-3[1]) (The rate of device success during the in-hospital) Freedom from mortality Freedom from surgery or intervention related to the device or a major vascular or access-related or cardiac structural complication Intended performance of the valve (mean gradient < 20 mmHg, peak velocity <3 m/s, and less than moderate aortic regurgitation)
    Time Frame
    Up to 1 week
    Title
    The rate of acceptable valve function at pre-discharge by echocardiogram defined as the following:
    Description
    Acceptable valve function at pre-discharge by echocardiogram (The rate of follow events during the follow-up) Freedom from moderate or greater patient-prosthesis mismatch (PPM) MPG <20mmHg Freedom from moderate or greater regurgitation (transvalvular and paravalvular) Freedom from reoperation or intervention
    Time Frame
    Up to 1 week
    Title
    The rate of freedom from severe coronary overlap assessed by post-implant angiogram
    Description
    Freedom from severe coronary overlap assessed by post-implant angiogram
    Time Frame
    immediately after the procedure
    Title
    The rate of freedom from mild or greater commissure misalignment assessed by post-implant angiogram and/or 30-day CT
    Description
    Freedom from mild or greater commissure misalignment assessed by post-implant angiogram and/or 30-day CT (post-implant 30-day CT scan is not mandatory for each subjects)
    Time Frame
    30-Days
    Title
    The rate of freedom from mild or greater PVL by echocardiogram during follow-up
    Description
    Freedom from mild or greater PVL by echocardiogram during follow-up
    Time Frame
    5 Years
    Title
    New York Heart Association (NYHA) classification during follow-up
    Description
    New York Heart Association (NYHA) classification during follow-up
    Time Frame
    5 Years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 18 years Patients with the symptoms of severe aortic stenosis Severe aortic stenosis (AS, grade 3+), defined as AVA ≤ 1 cm2 (AVAi ≤ 0.6 cm2/m3) or Vmax ≥ 4.0 m/s or MPG ≥ 40 mmHg determined by echocardiography Patients deemed for cardiac intervention by a heart team Patients of all surgical risk categories can be enrolled in this study, but should follows local medical practices and regulatories. Patients or their legal reprensentatives are willing to participate in the study and provide written informed consent, and agree to follow the follow-up requirements Exclusion Criteria: A subject meeting any of the following criteria shall be excluded: Co-morbidities Previous mechanical or biological aortic valve replacement Untreated mitral, tricuspid or pulmonary valve diseases requiring procedural intervention Acute myocardial infact within 30 days prior to index procedure Untreated clinical significant coronary artery disease requiring revascularization Any therapeutic invasive cardiac procedure performed within 30 days (or drug-eluting coronary stent/scaffold implant within 6 months) Sever symptomatic carotid artery stenosis Stroke or TIA within 3 months or Modified Rankin Scale ≥ 4 disability Chronic kidney disease (eGFR<30 mL/min/1.73m2) Haemotologic disorders: Leukopenia (WBC < 3000 cell/mL), anemia (Hgb < 9 g/dL), thrombocytopenia (Plt< 50,000 cell/mL), or any known blood clotting disorder, deemed clinically significant after consultation with Haematooncology specialists Severe right heart dysfunction Anatomical LVEF < 20% Echocardiographic evidence of intracardiac mass, thrombus, or vegetation Inappropriate anatomy for femoral introduction and delivery of study device Native aortic valve geometry and size unfavorable for study device anchoring General Haemodynamics instability requiring inotropic support or intra-aortic balloon pump (IABP) or other hemodynamic support device, or any mechanical heart assistance Known hypersensitivity or contraindication to antiplatelet, antithrombotic medications, or cobalt-chromium leading to be unable to undergo index procedure per physicians' judgement Life expectancy ≤ 1 year due to noncardiac reasons Active infection requiring antibiotic therapy including infective endocarditis Planned relevant concomitant procedure within 30 days post index procedure Pregnant, breastfeeding or intend to become pregnant within 1 year

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Venus-Vitae Pivotal Study Smart-Align Study

    We'll reach out to this number within 24 hrs