CHANGE Neo™ TA Registry With ACURATE Neo™ Aortic Bioprost... | NCT03454360

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

NCT03454360

Sponsor

Symetis SA

Status

Terminated

Last Update Posted

Dec 11, 2020Actual

Enrollment

107Actual

Phase

Not provided

Conditions

Aortic Stenosis

Interventions

ACURATE neo™ Aortic Bioprosthesis

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor business decision unrelated to product safety or efficacy.

Expanded Access Info

Start Date

Feb 6, 2018Actual

Primary Completion Date

Apr 30, 2020Actual

Completion Date

Apr 30, 2020Actual

First Submitted Date

Jul 31, 2017

First Submission Date that Met QC Criteria

Mar 2, 2018

First Posted Date

Mar 5, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2020

Last Update Posted Date

Dec 11, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

107Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ACURATE neo™ Aortic Bioprosthesis	Device	TAVI; Transcatheter Aortic Valve Replacement. Transapical Access.		ACURATE neo™ TA Delivery System

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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;

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Hilker, Prof.Dr.med	Universitätsklinikum Regensburg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kerckhoff Klinik		Bad Nauheim		61231	Germany
Herz-und Gefäß-Kilink GmbH

IPD Sharing Statement Module

Plan to Share IPD

Undecided

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).

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001024	Aortic Valve Stenosis

Ancestor Terms

ID	Term
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided