Venus-Vitae Pivotal Study Smart-Align Study
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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
Arms and Interventions
| 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.
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Outcome Measures
Primary Outcome Measures
- The rate of deaths at the one-year follow-up visit post procedure [1 Years]
All-cause mortality (The rate of deaths at the one-year follow-up visit post procedure)
- Acceptable Hemodynamic Performance at 30 days [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 [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
- Technical success is defined as the following [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
- The rate of device success is defined as the following [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)
- The rate of acceptable valve function at pre-discharge by echocardiogram defined as the following: [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
- The rate of freedom from severe coronary overlap assessed by post-implant angiogram [immediately after the procedure]
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 [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)
- The rate of freedom from mild or greater PVL by echocardiogram during follow-up [5 Years]
Freedom from mild or greater PVL by echocardiogram during follow-up
- New York Heart Association (NYHA) classification during follow-up [5 Years]
New York Heart Association (NYHA) classification during follow-up
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years
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Patients with the symptoms of severe aortic stenosis
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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
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Patients deemed for cardiac intervention by a heart team
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Patients of all surgical risk categories can be enrolled in this study, but should follows local medical practices and regulatories.
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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
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Previous mechanical or biological aortic valve replacement
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Untreated mitral, tricuspid or pulmonary valve diseases requiring procedural intervention
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Acute myocardial infact within 30 days prior to index procedure
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Untreated clinical significant coronary artery disease requiring revascularization
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Any therapeutic invasive cardiac procedure performed within 30 days (or drug-eluting coronary stent/scaffold implant within 6 months)
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Sever symptomatic carotid artery stenosis
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Stroke or TIA within 3 months or Modified Rankin Scale ≥ 4 disability
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Chronic kidney disease (eGFR<30 mL/min/1.73m2)
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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
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Severe right heart dysfunction Anatomical
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LVEF < 20%
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Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
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Inappropriate anatomy for femoral introduction and delivery of study device
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Native aortic valve geometry and size unfavorable for study device anchoring General
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Haemodynamics instability requiring inotropic support or intra-aortic balloon pump (IABP) or other hemodynamic support device, or any mechanical heart assistance
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Known hypersensitivity or contraindication to antiplatelet, antithrombotic medications, or cobalt-chromium leading to be unable to undergo index procedure per physicians' judgement
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Life expectancy ≤ 1 year due to noncardiac reasons
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Active infection requiring antibiotic therapy including infective endocarditis
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Planned relevant concomitant procedure within 30 days post index procedure
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Pregnant, breastfeeding or intend to become pregnant within 1 year
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Venus MedTech (HangZhou) Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VTAR-23-03