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NCT Number: NCT05991271

Venus-Vitae Pivotal Study Smart-Align Study

The purpose is to evaluate the safety, effectiveness and performance of Venus-Vitae Transcatheter Heart Valve System in patients with severe aortic stenosis.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Venus-Vitae Transcatheter Heart Valve System

Device

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Venus MedTech (HangZhou) Inc.

Industry

Registry information

Official study title

Multicenter Pivotal Study to Evaluate the Treatment of Severe Aortic Valve Stenosis With Next-Generation Venus-Vitae Transcatheter Heart Valve (THV) System

Important dates

Study start
2023
Primary completion
2024
Study completion
2029
First posted
Aug 14, 2023
Registry last updated
Aug 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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