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Venus-Vitae Pivotal Study Smart-Align Study

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ClinicalTrials.gov Identifier: NCT05991271
Recruitment Status : Not yet recruiting
First Posted : August 14, 2023
Last Update Posted : August 18, 2023
Sponsor:
Information provided by (Responsible Party):
Venus MedTech (HangZhou) Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Device: Venus-Vitae Transcatheter Heart Valve System Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Pivotal Study to Evaluate the Treatment of Severe Aortic Valve Stenosis With Next-Generation Venus-Vitae Transcatheter Heart Valve (THV) System
Estimated Study Start Date : October 31, 2023
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : June 30, 2029

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: procedure
implant valve by TAVR
 Device: Venus-Vitae Transcatheter Heart Valve System
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.


Outcome Measures
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Primary Outcome Measures :
  1. The rate of deaths at the one-year follow-up visit post procedure [ Time Frame: 1 Years ]
    All-cause mortality (The rate of deaths at the one-year follow-up visit post procedure)

  2. Acceptable Hemodynamic Performance at 30 days [ Time Frame: 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 :
  1. Occurrence of the following adverse events echocardiogram during follow-up [ Time Frame: 5 Years ]

    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

  2. Technical success is defined as the following [ Time Frame: During the Procedure ]

    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

  3. The rate of device success is defined as the following [ Time Frame: Up to 1 week ]

    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)

  4. The rate of acceptable valve function at pre-discharge by echocardiogram defined as the following: [ Time Frame: Up to 1 week ]

    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

  5. The rate of freedom from severe coronary overlap assessed by post-implant angiogram [ Time Frame: immediately after the procedure ]
    Freedom from severe coronary overlap assessed by post-implant angiogram

  6. The rate of freedom from mild or greater commissure misalignment assessed by post-implant angiogram and/or 30-day CT [ Time Frame: 30-Days ]
    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)

  7. The rate of freedom from mild or greater PVL by echocardiogram during follow-up [ Time Frame: 5 Years ]
    Freedom from mild or greater PVL by echocardiogram during follow-up

  8. New York Heart Association (NYHA) classification during follow-up [ Time Frame: 5 Years ]
    New York Heart Association (NYHA) classification during follow-up


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Patients with the symptoms of severe aortic stenosis
  3. 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
  4. Patients deemed for cardiac intervention by a heart team
  5. Patients of all surgical risk categories can be enrolled in this study, but should follows local medical practices and regulatories.
  6. 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

  1. Previous mechanical or biological aortic valve replacement
  2. Untreated mitral, tricuspid or pulmonary valve diseases requiring procedural intervention
  3. Acute myocardial infact within 30 days prior to index procedure
  4. Untreated clinical significant coronary artery disease requiring revascularization
  5. Any therapeutic invasive cardiac procedure performed within 30 days (or drug-eluting coronary stent/scaffold implant within 6 months)
  6. Sever symptomatic carotid artery stenosis
  7. Stroke or TIA within 3 months or Modified Rankin Scale ≥ 4 disability
  8. Chronic kidney disease (eGFR<30 mL/min/1.73m2)
  9. 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
  10. Severe right heart dysfunction Anatomical
  11. LVEF < 20%
  12. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
  13. Inappropriate anatomy for femoral introduction and delivery of study device
  14. Native aortic valve geometry and size unfavorable for study device anchoring General
  15. Haemodynamics instability requiring inotropic support or intra-aortic balloon pump (IABP) or other hemodynamic support device, or any mechanical heart assistance
  16. Known hypersensitivity or contraindication to antiplatelet, antithrombotic medications, or cobalt-chromium leading to be unable to undergo index procedure per physicians' judgement
  17. Life expectancy ≤ 1 year due to noncardiac reasons
  18. Active infection requiring antibiotic therapy including infective endocarditis
  19. Planned relevant concomitant procedure within 30 days post index procedure
  20. Pregnant, breastfeeding or intend to become pregnant within 1 year
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Venus MedTech (HangZhou) Inc.
ClinicalTrials.gov Identifier: NCT05991271    
Other Study ID Numbers: VTAR-23-03
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: August 18, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Aortic Valve Disease
 Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction