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

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

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.

Study Overview

• Status: Terminated
• Conditions: Aortic Stenosis
• Intervention / Treatment: Device: ACURATE neo™ Aortic Bioprosthesis

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 Type: Observational
• Enrollment (Actual): 107

Contacts and Locations

Study Locations

• Germany
  • Bad Nauheim, Germany, 61231
    • Kerckhoff Klinik
  • Bad Neustadt an der Saale, Germany, 97616
    • Herz-und Gefäß-Kilink GmbH
  • Bad Oeynhausen, Germany, D-32545
    • Krankenhausbetriebgesellschaft
  • Bochum, Germany, 44789
    • BG Klinik Bergmannsheil
  • Frankfurt, Germany, 60590
    • Universitätsklinikum Frankfurt- Klinik für Thorax, Herz und thorakale Gefæßchirurgie
  • Freiburg, Germany, 79106
    • Universitäts-Herzzentrum Freiburg-Bad Krozingen
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg-Eppendorf
  • Leipzig, Germany, 04289
    • Herzzentrum Leipzig
  • München, Germany, 80636
    • Deutsches Herzzentrum München
  • Regensburg, Germany, 93053
    • Universitätsklinikum Regensburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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;

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality	the rate of all-cause mortality as measured at 30-days	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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.
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
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.
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
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;

Collaborators and Investigators

• Sponsor: Symetis SA
• Investigators: Principal Investigator: Michael Hilker, Prof.Dr.med, Universitätsklinikum Regensburg

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2018
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: July 31, 2017
• First Submitted That Met QC Criteria: March 2, 2018
• First Posted (Actual): March 5, 2018

Study Record Updates

• Last Update Posted (Actual): December 11, 2020
• Last Update Submitted That Met QC Criteria: December 10, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Transcatheter Aortic Valve Replacement; TAVI; Transcatheter Aortic Valve; Transapical Access
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 2016-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: 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).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No