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

Aortic Stenosis Clinical Trial

Official title:

Collection of Specific Health And Patient Related Criteria Used to Select traNsapical TAVI Treatment and correspondinG outcomEs: CHANGE Neo™ TA Registry

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03454360
• Other study ID #: 2016-03
• Status: Terminated
• Start date: February 6, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: December 2020
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 107
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria:

• Symptomatic patients with severe aortic stenosis;
• Institution heart team determines that aortic valve replacement ACURATE neoTM device using its transapical delivery system is appropriate;

Exclusion criteria:

• Patients unable or unwilling to give inform consent;

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis

Intervention

Device:
• ACURATE neo™ Aortic Bioprosthesis
TAVI; Transcatheter Aortic Valve Replacement. Transapical Access.

Locations

Country	Name	City	State
Germany	Kerckhoff Klinik	Bad Nauheim
Germany	Herz-und Gefäß-Kilink GmbH	Bad Neustadt an der Saale
Germany	Krankenhausbetriebgesellschaft	Bad Oeynhausen
Germany	BG Klinik Bergmannsheil	Bochum
Germany	Universitätsklinikum Frankfurt- Klinik für Thorax, Herz und thorakale Gefæßchirurgie	Frankfurt
Germany	Universitäts-Herzzentrum Freiburg-Bad Krozingen	Freiburg
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Herzzentrum Leipzig	Leipzig
Germany	Deutsches Herzzentrum München	München
Germany	Universitätsklinikum Regensburg	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
Symetis SA

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality	the rate of all-cause mortality as measured at 30-days	30 days
Secondary	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	Procedure to Discharge, 30 days and 12-months
Secondary	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.	Procedure to 24-hours
Secondary	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.	Post-procedure to Discharge.
Secondary	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	30-days
Secondary	Functional improvement as per NYHA Functional Classification	Change on NYHA Class between baseline and different follow-up	from baseline to, discharge, 30-days and 12-months follow-up.
Secondary	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;	from baseline to discharge, 30- days and 12 months follow-up
Secondary	Total Aortic Regurgitation	Change on Aortic Regurgitation over time at follow-up	post-procedure, prior to discharge, at 30-days and 12-months follow-up;