ACURATE™ Transapical Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Symptomatic Stenosis
- Sponsor
- Symetis SA
- Enrollment
- 50
- Locations
- 5
- Primary Endpoint
- Freedom from all-cause mortality at 30 day Follow Up
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to evaluate safety of the study device and study device performance in patients presenting with severe aortic stenosis who are considered to be high risk for open surgical repair.
Detailed Description
A single arm, prospective, multicenter, non-randomized, and open trial, up to 5 years follow-up with the Symetis ACURATE TA™ which is an aortic bioprosthesis for minimal invasive implantation vie transapical access to treat patients with severe symptomatic aortic stenosis where conventional aortic valve replacement (AVR) via open heart surgery is considered to be associated with high surgical risk for evaluating safety and performance of the implantation and safety at 30-D follow-up.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients at least 75 years of age
- •Additive EuroSCORE \> 9
- •Severe AS assessed by echocardiography and documented by a mean gradient \> 40mmHg and a native Aortic Valve Area (AVA) \< 0.8 cm² or Aortic Valve Area Index (AVAI) \< 0.6 cm²/m²
- •NYHA Functional Class \> II
- •Aortic annulus (AAn) diameters between and including 21 mm up to 27 mm (21mm ≤ AAn ≤27mm) by transoesophageal echocardiography (TEE)
- •Patient understands the implications of participating in the study and provides signed informed consent
Exclusion Criteria
- •Congenital unicuspid or bicuspid aortic valve
- •Severe eccentricity of calcification
- •Severe mitral regurgitation (\> 2°)
- •Pre-existing prosthetic heart valve in any position and / or prosthetic ring
- •Severe transapical access problem, non-reachable LV apex
- •Previous surgery of the LV using a patch, such as the Dor procedure
- •Presence of apical LV thrombus
- •Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
- •Acute myocardial infarction (AMI) within 1 month prior to the procedure
- •PCI within 1 month prior to the procedure
Outcomes
Primary Outcomes
Freedom from all-cause mortality at 30 day Follow Up
Time Frame: 30-Day Follow-up
The primary study objective is to evaluate the safety of the ACURATE™ Transapical Aortic Bioprosthesis at 30 days post-procedure in patients presenting with severe aortic valve stenosis at high risk for conventional AVR surgery.
Freedom from all-cause mortality at 12 months Follow Up
Time Frame: 12 months Follow-Up
The primary study objective is to evaluate the safety of the ACURATE™ Transapical Aortic Bioprosthesis at 12 months post-procedure in patients presenting with severe aortic valve stenosis at high risk for conventional AVR surgery.
Secondary Outcomes
- Rate of Major Adverse Cardiac and Cerebrovascular-Related Events (MACCE) at 30 days and at 12 Month and defined as cardiovascular death, myocardial infarction and stroke.(30-Day and 12-Month)
- Device success at 30 Days and 12 Month follow-up as defined as adequate functioning of the study device as confirmed by angiography and/or echocardiography as assessed at a CoreLab.(30-Day and 12-Month Follow-up)
- Rate of Major Adverse Valve-Related Events (MAVRE) at 30 days and at 12 month follow up related to the study device as defined as;(30-Days and at 12 Months Follow-up)
- Functional Improvement from baseline(30-Days and 12-Month Follow-up)
- Procedural success(24 hours Post-Procedure)