ACURATE Neo™ Aortic Bioprosthesis for Implantation Using the ACURATE Neo™ TA Transapical Delivery System in Patients With Severe Aortic Stenosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Stenosis
- Sponsor
- Symetis SA
- Enrollment
- 60
- Locations
- 7
- Primary Endpoint
- Primary Safety: freedom from all-cause mortality
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this investigation is to collect data pertaining to the safety and performance of the ACURATE neo (TM) Aortic Bioprosthesis as implanted with the ACURATE neo (TM) TA Transapical Delivery System. This device is intended for treatment of subjects with severe aortic stenosis (AS) who have high risk for conventional aortic valve replacement (AVR) surgery. The ACURATE neo (TM) Aortic Bioprosthesis is intended for use via minimally-invasive transapical implantation in a well-defined population.
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
- •Subject must be at least 18 years old
- •Severe aortic stenosis defined as:
- •Mean aortic gradient \> 40 mmHg or
- •Peak jet velocity \> 4.0 m/s or
- •Aortic valve area of \< 0.8 cm2
- •High risk patient determined by a multidisciplinary heart team consensus (cardiologist and cardiac surgeon) that patient is not a surgical candidate for conventional AVR due to risk factors such as STS Score (8% or higher) or other co-morbid conditions unrelated to aortic stenosis such as severe chronic obstructive pulmonary disease (COPD), chest deformities and irradiated mediastinum
- •NYHA Functional Class \> II
- •Multidisciplinary heart team (cardiologist and cardiac surgeon) consensus that the transapical approach is the most suitable access route for TAVI due to the presence of the following anatomic conditions:
- •porcelain aorta or
- •severely calcified or highly tortuous peripheral vasculature not appropriate for transfemoral transcatheter aortic valve implantation or
Exclusion Criteria
- •Congenital unicuspid or bicuspid aortic valve or non-calcified
- •Extreme eccentricity of calcification
- •Severe mitral regurgitation (\> Grade 3)
- •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
Primary Safety: freedom from all-cause mortality
Time Frame: 6 months post procedure
freedom from all-cause mortality
Primary Device Performance:Procedure success in absence of MACCE
Time Frame: 30 days post procedure
Procedure success in absence of MACCE
Secondary Outcomes
- NYHA Functional Classification improvement(30 Days, 6 Month and at 12 Months)
- Incidence of all cause mortality at 30 Days and 12 Months(30 days and 12 months)
- Rate of device success(7 days/ Discharge, 30 Days, 6 Months and at 12 Months)
- Echocardiographic assessment of valve performance (at 7 Days or Discharge, 30 Days, 6 Months, 12 Months) using a combination of measures(7 Days or Discharge, 30 Days, 6 Months, 12 Months)
- Rate of clinical endpoints according to the Valve Academic Research Consortium (VARC 2) guidelines(30 Days and month 12)
- Freedom from MACCE at 30 Days, 6 Months and 12 Months(30 Days, 6 Months and 12 Months)
- Number of patients who have a Procedural success defined by a combination of criteria(procedure)