ACURATE Neo™ AS Aortic Bioprosthesis for Implantation Using the ACURATE neoTM AS TF Transfemoral Delivery System in Patients With Severe Aortic Stenosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Stenosis
- Sponsor
- Symetis SA
- Enrollment
- 120
- Locations
- 9
- Primary Endpoint
- Rate of all-cause mortality at 30 days follow-up
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
Clinical trial aimed at evaluating the safety and performance of the ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System for CE mark approval purposes.
Detailed Description
Single arm, prospecitve, multicenter, non-randomized and open trial. The purpose of this trial is to collect and safety and performance data concerning the ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System The ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System are intended for use in minimally invasive, transcatheter aortic valve replacement (TAVR) using transfemoral access in patients presenting with severe aortic valve stenosis. The primary objective is to evaluate the safety and performance of the study device in patients presenting with severe aortic stenosis (AS) considered to be high risk for surgery. The secondary objective is to evaluate adverse events and study device performance.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient 75 years of age and older
- •Severe aortic stenosis defined as:
- •Mean aortic gradient \> 40 mmHg or
- •Peak jet velocity \> 4.0 m/s or
- •Aortic valve area of \< 1.0 cm2
- •High risk candidate for conventional AVR defined as:
- •Logistic EuroSCORE 1 ≥ 20% or
- •STS Score ≥ 8% or
- •Heart team (cardiologist and cardiac surgeon) consensus that patient is not a surgical candidate for conventional AVR due to significant co-morbid conditions unrelated to aortic stenosis
- •NYHA Functional Class \> II
Exclusion Criteria
- •Congenital aortic stenosis or unicuspid or bicuspid aortic valve
- •Non-stenotic Aortic Insufficiency
- •Severe eccentricity of calcification
- •Severe mitral regurgitation (\>2+)
- •Presence of mitral bioprosthesis
- •Presence of previously implanted aortic bioprosthesis
- •Presence of prosthetic ring
- •Anatomy NOT appropriate for transfemoral implant due to the size, disease and degree of calcification or tortuosity of the aorta or ilio-femoral arteries
- •Thoracic (TAA) or abdominal (AAA) aortic aneurysm
- •Presence of endovascular stent graft for treatment of TAA or AAA
Outcomes
Primary Outcomes
Rate of all-cause mortality at 30 days follow-up
Time Frame: 30 days post-implant
Secondary Outcomes
- Rate of clinical events as defined per VARC guidelines(7 days, 30 days, 12 months post-implant)
- Procedural success(Day of implant)
- Device success(Day of implant)
- VARC Composite Safety at 30 days(30 days)
- Clinical improvement from baseline as per NYHA Functional Classification(7 days, 30 days, 12 months post-implant)
- Improvement from baseline in hemodynamic function: effective orifice area, mean transprosthetic gradient(7 days, 30 days, 12 months)
- Total aortic regurgitation(7 days, 30 days, 12 months)