An observational study in Aortic Stenosis, sponsored by Symetis SA. Terminated at 10 sites in Germany. Per ClinicalTrials.gov, last updated 2020-12-11.
Sponsored by Symetis SA · Observational
The purpose of this registry is to collect specific health and patient data to identify more precisely the patient population undergoing TA aortic valve replacement with the ACURATE neo™ Aortic biprosthesis and ACURATE neo™ TA Transapical Delivery System.
Safety and efficacy data will be collected to support the commercial use of the ACURATE neo™ Aortic Bioprosthesis and ACURATE neo™ TA Transapical Delivery System in a specific TA population.
As per IFU, the ACURATE neo™ and its ACURATE neo™ TA Delivery System are intended for use in minimally invasive, transcatheter aortic valve replacement using transapical access in patients presenting with severe aortic valve stenosis.
The Primary Objective of this post-market registry is to collect specific health and patient characteristics to understand the indication for TA-TAVI and to further evaluate the safety and performance of the ACURATE neo ™ Aortic Bioprosthesis and ACURATE neo™ TA Transapical Delivery System in a specific TA population, consisting of 200 consented patients.
All subjects with severe aortic stenosis, for whom the transapical access is the most suitable approach as per heart-team consensus, who signed the Informed Consent Form (ICF) approved by the Independent Ethics Committee (IEC), and are deemed to be candidates to undergo transcatheter aortic valve implantation with the ACURATE neo™ Aortic Bioprosthesis and its Transapical Delivery System as per clinical practice at each participating site
Exclusion criteria:
TAVI; Transcatheter Aortic Valve Replacement. Transapical Access.
Also known as: ACURATE neo™ TA Delivery System
All cause mortality
the rate of all-cause mortality as measured at 30-days
Time frame: 30 days
Safety and performance data will be collected to support the commercial use of the ACURATE neo ™ Aortic Bioprosthesis and ACURATE neo™ TA Transapical Delivery System in a specific TA population.
Clinical events as defined per VARC 2 consensus document at procedure: All cause mortality; Stroke; Myocardial Infarction; Bleeding complication; Acute kidney injury; Vascular complication; Conduction disturbances and arrhythmia; Other TAVI-related complications
Time frame: Procedure to Discharge, 30 days and 12-months
Procedural Success
Defined as absence of intra-procedure mortality (procedure to 24H) AND absence of complications arising during implantation of the prosthetic valve such as: inability to properly seat the valve in the annulus; need for more than one implanted aortic bioprosthesis (valve-in-valve or ectopic deployment) or if a surgical aortic valve replacement is required to correct a severe aortic regurgitation or procedure complication. The procedure can be considered as success despite the presence of residual aortic regurgitation, which may be due to the anatomic configuration of the annulus or a calcific valvular annulus.
Time frame: Procedure to 24-hours
Device Success
Defined as; * Absence of intra-procedure mortality (procedure to 24H) AND, * Correct positioning (placement in the annulus with no impairment of aortic bioprosthesis function) of a single prosthetic heart valve into the proper anatomical location AND, * Intended performance of the prosthetic heart valve assessed prior to discharge per local standard of care and defined as: * No prosthesis-patient mismatch (EAOi \>0.85 cm2/m2 or EAOi \>0.7 cm2/m2 for BMI ≥30 kg/m2) ) AND, * Mean aortic valve gradient \<20mmHg or peak velocity \< 3 m/s AND, * No moderate or severe prosthetic valve regurgitation. For echo parameters for the performance assessment, a pre-discharge echo examination should be performed as per local standard of care. If echo parameter pre-discharge is missing, any echo parameter within 45 days post-procedure may be used.
Time frame: Post-procedure to Discharge.
VARC 2 Composite Safety
Defined as: * All-cause mortality * All stroke * Life-threatening bleeding * Acute Kidney Injury- Stage 2 or 3 * Coronary Artery Obstruction requiring intervention * Major Vascular Complications * Valve-related dysfunction requiring repeat procedure
Time frame: 30-days
Functional improvement as per NYHA Functional Classification
Change on NYHA Class between baseline and different follow-up
Time frame: from baseline to, discharge, 30-days and 12-months follow-up.
Improvement of EOA and mean Trans-prosthetic gradient
If the echo parameter pre-discharge is missing to assess the intended performance, any echo parameter data within 45-days post procedure may be used for the missing values;
Time frame: from baseline to discharge, 30- days and 12 months follow-up
Total Aortic Regurgitation
Change on Aortic Regurgitation over time at follow-up
Time frame: post-procedure, prior to discharge, at 30-days and 12-months follow-up;
Plan to share: Undecided — The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html).
No publications or documents are linked to this record.
This study is terminated, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Symetis SA