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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04655248




Registration number
NCT04655248
Ethics application status
Date submitted
30/11/2020
Date registered
7/12/2020

Titles & IDs
Public title
ACURATE Neo2™ Post Market Clinical Follow Up Study
Scientific title
ACURATE Neo2™ Post Market Clinical Follow Up Study
Secondary ID [1] 0 0
S2410
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Valve Stenosis 0 0
Aortic Valve Calcification 0 0
Aortic Diseases 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Transcatheter Aortic Valve Implantation/Replacement

Treatment: Devices: Transcatheter Aortic Valve Implantation/Replacement
The device is placed in patients heart at the level of aortic valve through a transfemoral access from femoral groin as indicated in device IFU
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Safety Endpoint:
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
Primary Imaging Endpoint:
Timepoint [2] 0 0
30 days
Secondary outcome [1] 0 0
Safety endpoints adjudicated by an independent Clinical Events Committee
Timepoint [1] 0 0
all 5 years
Secondary outcome [2] 0 0
Additional Safety Endpoints
Timepoint [2] 0 0
all 5 years
Secondary outcome [3] 0 0
Prosthetic Aortic Valve Performance as measured by transthoracic echocardiography (TTE)
Timepoint [3] 0 0
Discharge, 30 days, annually from year 1 to 5
Secondary outcome [4] 0 0
EuroQoL Quality of Life questionnaire (EQ-5D-5L)
Timepoint [4] 0 0
Baseline, 30-day, 1-year
Secondary outcome [5] 0 0
New York Heart Association (NYHA) functional classification
Timepoint [5] 0 0
Baseline, Discharge, 30 days, annually from year 1 to 5
Secondary outcome [6] 0 0
Assessments using 4D CT-scan
Timepoint [6] 0 0
30 days 1 year

Eligibility
Key inclusion criteria
There are no specific inclusion criteria set for this post-market surveillance study. A subject must sign an IEC-approved ICF and the ACURATE neo2 Transfemoral Aortic Valve System should be used according to the commercial IFU.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
EC1. Subject has a previous bioprosthesis in the aortic position.

EC2. Subject has eGFR <30 mL/min (chronic kidney disease stage IV or stage V).

EC3. Subject has atrial fibrillation that cannot be rate controlled to ventricular response rate < 60 bpm.

EC4. Subject is expected to undergo chronic anticoagulation therapy after the TAVI procedure

Note : Subjects treated with short-term anticoagulation post-procedure can be included; in these subjects the 30-day imaging will be performed 30 days after discontinuation of anticoagulation.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
Accrual to date
Final
250
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Aarhus
Country [2] 0 0
Denmark
State/province [2] 0 0
Copenhagen
Country [3] 0 0
Denmark
State/province [3] 0 0
Odense
Country [4] 0 0
Germany
State/province [4] 0 0
Bad Nauheim
Country [5] 0 0
Germany
State/province [5] 0 0
Bad Oeynhausen
Country [6] 0 0
Germany
State/province [6] 0 0
Dortmund
Country [7] 0 0
Germany
State/province [7] 0 0
Regensburg
Country [8] 0 0
Italy
State/province [8] 0 0
CA
Country [9] 0 0
Italy
State/province [9] 0 0
Milano
Country [10] 0 0
Italy
State/province [10] 0 0
Pisa
Country [11] 0 0
Netherlands
State/province [11] 0 0
Rotterdam
Country [12] 0 0
Netherlands
State/province [12] 0 0
Utrecht
Country [13] 0 0
Spain
State/province [13] 0 0
Santiago De Compostela
Country [14] 0 0
Spain
State/province [14] 0 0
Valladolid
Country [15] 0 0
Sweden
State/province [15] 0 0
Lund
Country [16] 0 0
Sweden
State/province [16] 0 0
Stockholm
Country [17] 0 0
Switzerland
State/province [17] 0 0
Zürich
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Liverpool
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Won-Keun Kim, MD
Address 0 0
Kerckhoff Klinik
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
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)


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04655248