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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
ACURATE neo™ Aortic Bioprosthesis and ACURATE neo™TA Transapical Delivery System on patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via open-heart surgery is considered to be high risk
Kerckhoff-Klinik
Bad Nauheim, Germany
Krankenhausbetriebsgesellschaft
Bad Oeynhausen, Germany
Deutsched Herzzentrum Berlin
Berlin, Germany
Martin Luther University Halle Winttenberg
Halle, Germany
Primary Safety: freedom from all-cause mortality
freedom from all-cause mortality
Time frame: 6 months post procedure
Primary Device Performance:Procedure success in absence of MACCE
Procedure success in absence of MACCE
Time frame: 30 days post procedure
Rate of clinical endpoints according to the Valve Academic Research Consortium (VARC 2) guidelines
VARC 2 guidelines include different safety and efficacy endpoints like mortality, MI, stroke, etc.
Time frame: 30 Days and month 12
Incidence of all cause mortality at 30 Days and 12 Months
Incidence of all cause mortality at 30 Days and 12 Months
Time frame: 30 days and 12 months
Freedom from MACCE at 30 Days, 6 Months and 12 Months
Freedom from MACCE at 30 Days, 6 Months and 12 Months
Time frame: 30 Days, 6 Months and 12 Months
Number of patients who have a Procedural success defined by a combination of criteria
Procedural success defined as ACURATE neo™ at intended location with
Time frame: procedure
Rate of device success
Rate of device success
Time frame: 7 days/ Discharge, 30 Days, 6 Months and at 12 Months
NYHA Functional Classification improvement
NYHA Functional Classification improvement
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Universitätklinikum Hamburg Eppendorf
Hamburg, Germany
Herzentrum Leipzig GmbH
Leipzig, Germany
University Hospital Regensburg
Regensburg, Germany
Time frame: 30 Days, 6 Month 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
Echocardiographic assessment of valve performance (at 7 Days or Discharge, 30 Days, 6 Months, 12 Months) using a combination of measures
Time frame: 7 Days or Discharge, 30 Days, 6 Months, 12 Months