Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2025-12-26 @ 4:18 PM
Study NCT ID:
NCT04810195
Status:
COMPLETED
Last Update Posted:
2022-10-05
First Post:
2021-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early neo2 Registry of the Acurate neo2 TAVI Prosthesis
Sponsor:
Andreas Rück
Organization:
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:
False
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?: