Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-02-25 @ 8:58 PM
Study NCT ID:
NCT02987894
Status:
COMPLETED
Last Update Posted:
2020-04-09
First Post:
2016-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PRospective Observation of Aortic reGuRgitation aftEr TAVI and progreSS Over Time: PROGRESS PVL Registry
Sponsor:
Symetis SA
Organization:
Study Overview
Official Title:
Prospective Observation of Aortic Regurgitation After TAVI and Progress Over Time: PROGRESS PVL Registry
Status:
COMPLETED
Status Verified Date:
2020-04
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:
PROGRESS
Brief Summary:
The purpose of this post-market registry is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo™ Aortic Bioprosthesis, and the ACURATE TF™ Transferral Delivery System, when used as per IFU.
Detailed Description:
The primary objective of this post-market registry is to further evaluate the safety and performance of the ACURATE neo™ Aortic Bioprosthesis and the ACURATE TF™ Transferral Delivery System in 500 consented patients with severe aortic stenosis and treated according to the instructions for use (IFU).
Examinations to evaluate the aortic valve regurgitation performed as standard of care in patients undergoing transcatheter aortic valve replacement will be analyzed by an external Core Laboratory. These examinations are limited to echocardiography and/or contrast aortography assessments.
The secondary objective is to collect adverse events and evaluate them according to the VARC-2 consensus document.
Examinations to evaluate the aortic valve regurgitation performed as standard of care in patients undergoing transcatheter aortic valve replacement will be analyzed by an external Core Laboratory. These examinations are limited to echocardiography and/or contrast aortography assessments.
The secondary objective is to collect adverse events and evaluate them according to the VARC-2 consensus document.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: