Ignite Creation Date:
2024-05-06 @ 3:57 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04810195
Status:
COMPLETED
Last Update Posted:
2022-10-05
First Post:
2021-03-07
Brief Title:
Early neo2 Registry of the Acurate neo2 TAVI Prosthesis
Sponsor:
Andreas Rück
Organization:
Karolinska University Hospital
Study Overview
Official Title:
Early neo2 Registry of the Acurate neo2 TAVI Prosthesis
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None