CHANGE Neo™ TA Registry With ACURATE Neo™ Aortic Bioprosthesis and ACURATE Neo™ TA Transapical Delivery System

Terminated

• Conditions: Aortic Stenosis

• Registration Number: NCT03454360
• Lead Sponsor: Symetis SA

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-07-31
• Study Start: 2018-02-06
• Study First Submitted QC: 2018-03-02
• Study First Posted: 2018-03-05
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-10
• Last Update Posted: 2020-12-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All cause mortality	30 days	the rate of all-cause mortality as measured at 30-days

Secondary Outcome Measures

Name	Time	Method
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.	Procedure to Discharge, 30 days and 12-months	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
Procedural Success	Procedure to 24-hours	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.
Device Success	Post-procedure to Discharge.	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.
VARC 2 Composite Safety	30-days	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
Functional improvement as per NYHA Functional Classification	from baseline to, discharge, 30-days and 12-months follow-up.	Change on NYHA Class between baseline and different follow-up
Improvement of EOA and mean Trans-prosthetic gradient	from baseline to discharge, 30- days and 12 months follow-up	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;
Total Aortic Regurgitation	post-procedure, prior to discharge, at 30-days and 12-months follow-up;	Change on Aortic Regurgitation over time at follow-up

Trial Locations

Locations (10)

BG Klinik Bergmannsheil; 🇩🇪 Bochum, Germany

Universitäts-Herzzentrum Freiburg-Bad Krozingen; 🇩🇪 Freiburg, Germany

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Herz-und Gefäß-Kilink GmbH; 🇩🇪 Bad Neustadt an der Saale, Germany

Universitätsklinikum Frankfurt- Klinik für Thorax, Herz und thorakale Gefæßchirurgie; 🇩🇪 Frankfurt, Germany

Kerckhoff Klinik; 🇩🇪 Bad Nauheim, Germany

Deutsches Herzzentrum München; 🇩🇪 München, Germany

Krankenhausbetriebgesellschaft; 🇩🇪 Bad Oeynhausen, Germany

Herzzentrum Leipzig; 🇩🇪 Leipzig, Germany

Universitätsklinikum Regensburg; 🇩🇪 Regensburg, Germany