Early neo2 Registry of the Acurate neo2 TAVI Prosthesis | NCT04810195

Studies
Early neo2 Registry of the Acurate neo2 TAVI Prosthesis

NCT04810195

Sponsor

Andreas Rück

Status

Completed

Last Update Posted

Oct 5, 2022Actual

Enrollment

554Actual

Phase

Not provided

Conditions

Aortic Valve Stenosis

Interventions

Boston Scientific Acurate neo2 TAVR device

Countries

Denmark
Germany
Sweden

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

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Actual

Primary Completion Date

Apr 1, 2021Actual

Completion Date

Mar 15, 2022Actual

First Submitted Date

Mar 7, 2021

First Submission Date that Met QC Criteria

Mar 19, 2021

First Posted Date

Mar 22, 2021Actual

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

Oct 3, 2022

Last Update Posted Date

Oct 5, 2022Actual

Name	Class
Boston Scientific Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The Early neo2 registry will study up to 500 patients treated with the updated Boston Acurate neo2 TAVI prosthesis at various European hospitals. The data is gathered from routine healthcare and there are no study-mandated additional procedures. The main endpoint is a combined efficiency and safety endpoint after 30 days. Imaging data (echocardiography, computed tomography and aortography) will be analysed centrally by a core lab.

Detailed Description

Background and rationale The Boston Scientific Acurate neo2 TAVI prosthesis was launched commercially in Europe in September 2020 as a successor to the original Acurate neo prosthesis. Modifications include an added sealing skirt. The original Acurate neo failed to reach non-inferiority to other TAVI prostheses in two randomized trials. There is a need to gather initial safety and efficacy data from this next generation prosthesis, as there is no larger dataset presented after the CE-mark study of the Acurate neo2.

Project objectives To gather initial safety and efficacy data in the initial up to 500 consecutive patients treated with the Acurate neo2 in various European sites.

Karolinska will be the coordinating center for data collection.

Methods Data will be collected in an anonymous form and sent to Karolinska for compilation and statistics. Data collection will continue until 500 patients are reached (April, 2021).

Statistics Standard descriptive statistics will be used for the main results. For the comparison to SCOPE data (with the original Acurate neo prosthesis) on postoperative aortic insufficiency, standard statistical methods will used (Fishers exact test for categorical variables, and t-test for continuous measurements such as amount of regurgitation by videodensitometry).

Core lab studies The core lab analyses will be performed at CORRIB in Galway (Prof. Serruys et al).

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

554Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Boston Scientific Acurate neo2 TAVR device	Device	The newest generation of the Acurate neo2 TAVR device, launched in Europe in 2020.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MACE	any of Postoperative aortic insuffiency moderate or higher (in hospital echo, site reported) Postoperative new permanent pacemaker (in hospital) 30 days mortality 30 days stroke Acute Kidney Injury (AKIN grade 3) (in hospital)	30 days

Secondary Outcomes

Measure	Description	Time Frame
Rate of Postoperative aortic insufficiency more than mild by transthoracic echo	Core-lab analysis of the postoperative transthoracic echo for aortic insufficiency: percentage of patients with more than mild insufficiency	Within 7 days of procedure
Rate of Postoperative aortic insufficiency more than mild by aortography

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

that a Acurate neo2 prosthesis has been inserted into the sheath (i.e. a procedure has been started).

Exclusion Criteria:

None

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

The first 500 consecutive patients treated with the Acurate neo2 from up to 15 European sites which have started using the Acurate neo2.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andreas Rück, MD PhD	Karolinska University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet		Copenhagen			Denmark
Kerckhoff Klinik

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

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

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Browse Branches

Not provided