NCT05991271Not yet recruitingNot Applicable
Multicenter Pivotal Study to Evaluate the Treatment of Severe Aortic Valve Stenosis With Next-Generation Venus-Vitae Transcatheter Heart Valve (THV) System
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 150
- Primary Endpoint
- The rate of deaths at the one-year follow-up visit post procedure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
procedure
Experimental
implant valve by TAVR
Intervention: Venus-Vitae Transcatheter Heart Valve System (Device)
Outcomes
Primary Outcomes
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)
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
- The rate of freedom from mild or greater commissure misalignment assessed by post-implant angiogram and/or 30-day CT(30-Days)
- Technical success is defined as the following(During the Procedure)
- The rate of device success is defined as the following(Up to 1 week)
- The rate of acceptable valve function at pre-discharge by echocardiogram defined as the following:(Up to 1 week)
- New York Heart Association (NYHA) classification during follow-up(5 Years)
- The rate of freedom from mild or greater PVL by echocardiogram during follow-up(5 Years)
- Occurrence of the following adverse events echocardiogram during follow-up(5 Years)
- The rate of freedom from severe coronary overlap assessed by post-implant angiogram(immediately after the procedure)
Investigators
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