ACURATE Neo™ Aortic Bioprosthesis for Implantation Using the ACURATE TA™ LP Transapical Delivery System in Patients With Severe Aortic Stenosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Stenosis
- Sponsor
- Symetis SA
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- All cause mortality
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
Trial of ACURATE neo(TM) Aortic Bioprosthesis for Implantation using the ACURATE TA(TM) LP Transapical Delivery System in Patients with Severe Aortic Stenosis for evaluating the Safety and performance of the study device
Detailed Description
This is a single arm, prospective, multicenter non randomised and open trial of the treatment of patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via open heart surgery is considered to be high risk. All patients will be followed up to 5 years after the intervention. The primary objective is to evaluate the safety and performance of the study device in patients presenting with severe aortic stenosis considered to be high risk for surgery 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 \> 40mmHg or o Peak jet velocity \> 4.0m/sor Aortic valve area of \< 1.0cm2
- •High risk candidate for conventional AVR defined as:
- •STS score ≥ 10 or Multidisciplinary 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
- •Multidisciplinary heart team (cardiologist and cardiac surgeon) consensus that the transapical approach is the most suitable TAVI access route
- •Aortic annulus diameter from ≥ 21mm up to ≤ 27mm by CT or TEE
- •Patient willing to participate in the study and provides signed informed consent
Exclusion Criteria
- •Congenital unicuspid or bicuspid aortic valve
- •Extreme eccentricity of calcification
- •Severe mitral regurgitation (\> Grade 2)
- •Pre-existing prosthetic heart valve in any position and / or prosthetic ring
- •LV apex is not accessible via transapical access due to severe chest deformity
- •Previous surgery of the LV using a patch, such as the Dor procedure
- •Presence of apical LV thrombus
- •Calcified pericardium
- •Septal hypertrophy unacceptable for transapical procedure
- •Transesophageal echocardiogram (TEE) is contraindicated
Outcomes
Primary Outcomes
All cause mortality
Time Frame: 30 days
incidence of all cause mortality at 30 days
Mean aortic gradient after device implantation
Time Frame: 7 days or Discharge
mean aortic gradient evaluated by echocardiography and by the site at 7days or discharge per standard post-implantation follow-up
Secondary Outcomes
- rate of clinical endpoints VARC II(30 days and month 12)
- device success assessed according to composite VARC 2 criteria(7 days, 30 days, 12 months)
- procedural success(procedure)
- functional improvement from Baseline as per NYHA Functional Classification(30 days and 12 months follow up)