Clinical trial NCT03454360: CHANGE Neo™ TA Registry With ACURATE Neo™ Aortic Bioprosthesis and ACURATE Neo™ TA Transapical Delivery System
Official title: Collection of Specific Health And Patient Related Criteria Used to Select traNsapical TAVI Treatment and correspondinG outcomEs: CHANGE Neo™ TA Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Aortic Stenosis
Keywords: TAVI
Transcatheter Aortic Valve Replacement
Transcatheter Aortic Valve
Transapical Access
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2018-03-05
Enrollment: 107
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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;

Primary outcomes:
measure: All cause mortality
timeFrame: 30 days
Secondary outcomes:
measure: 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.
timeFrame: Procedure to Discharge, 30 days and 12-months
measure: Procedural Success
timeFrame: Procedure to 24-hours
measure: Device Success
timeFrame: Post-procedure to Discharge.
measure: VARC 2 Composite Safety
timeFrame: 30-days
measure: Functional improvement as per NYHA Functional Classification
timeFrame: from baseline to, discharge, 30-days and 12-months follow-up.
measure: Improvement of EOA and mean Trans-prosthetic gradient
timeFrame: from baseline to discharge, 30- days and 12 months follow-up
measure: Total Aortic Regurgitation
timeFrame: post-procedure, prior to discharge, at 30-days and 12-months follow-up;
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik
city: Bad Neustadt an der Saale
country: Germany
facility: Herz-und Gefäß-Kilink GmbH
city: Bad Oeynhausen
country: Germany
facility: Krankenhausbetriebgesellschaft
city: Bochum
country: Germany
facility: BG Klinik Bergmannsheil
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt- Klinik für Thorax, Herz und thorakale Gefæßchirurgie
city: Freiburg
country: Germany
facility: Universitäts-Herzzentrum Freiburg-Bad Krozingen
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
city: München
country: Germany
facility: Deutsches Herzzentrum München
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
Study officials:
affiliation: Universitätsklinikum Regensburg
name: Michael Hilker, Prof.Dr.med
role: PRINCIPAL_INVESTIGATOR
References: