Ignite Creation Date:
2024-05-06 @ 3:31 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04659655
Status:
UNKNOWN
Last Update Posted:
2020-12-09
First Post:
2020-11-16
Brief Title:
VIenna Pilot Study for Automated Annular Suturing Technology
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
VIenna Pilot Study for Automated Annular Suturing Technology to Assist in Aortic Mitral Valve Replacement - A Single-center Clinical Safety Feasibility Pilot Trial
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
RECRUITING
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:
VIP-RAM
Brief Summary:
The objective of this study is to compare surgical outcomes between patients who underwent valve replacement with and without the help of the automated annular suturing technology In addition data of the early and intermediate postoperative period will be collected within routine clinical follow-up in order to assess morbidity and mortality as well as echocardiographic parameters
Detailed Description:
This study is a clinical single-center pilot-study to evaluate safety and performance 30 Patients n20 aortic valve replacement n10 mitral valve replacement with aortic and mitral valve pathology highly likely for prosthetic valve replacement who are planned for surgery at the Vienna General Hospital AKH will be included in this study with respect to the inclusion and exclusion criteria The patients will undergo aortic or prosthetic mitral valve replacement using a specified automated annular suturing system for placement of the annular pledgeted sutures
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?:
True
Is an FDA AA801 Violation?:
None