Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06412354
Status:
COMPLETED
Last Update Posted:
2024-05-14
First Post:
2024-04-30
Brief Title:
EasyCrossTM Device-Self-centering Catheter
Sponsor:
Vivheart srl
Organization:
Vivheart srl
Study Overview
Official Title:
VIVHEART Transcatheter Aortic Valve Replacement TAVR Self-centering Catheter First-in-human Feasibility Trial VIV-FIH
Status:
COMPLETED
Status Verified Date:
2024-05
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:
VIV-FIH
Brief Summary:
VIVHEART EasyCross is a self-centering device for inserting a guidewire through a heart valve It consists in a temporary catheter inserted into an artery with a terminal part able to expand a distal structure with 6 arms basket to allow distancing of the catheter from the vessels walls and thus facilitating the passage of the guide wire through the aortic valve The device is expected to reduce the attempts and the time needed to cross the valve and improves the safety of TAVR procedure
Detailed Description:
VIVHEART EasyCross is a self-centering device for inserting a guidewire through a heart valve It consists in a temporary catheter inserted into an artery with a terminal part able to expand a distal structure with 6 arms basket to allow distancing of the catheter from the vessels walls and thus facilitating the passage of the guide wire through the aortic valve The device is expected to reduce the attempts and the time needed to cross the valve and improves the safety of TAVR procedure
EasyCross device is a catheter is intended to allow a rapid and safe centering of a heart valve in order to direct and introduce a guidewire through it The intended purpose is the use of the device during percutaneous TAVR procedures including TAVR of a native valve recrossing and balloon post-dilation of a prosthetic aortic valve or a valve-in-valve aortic valve replacement within the scope of the CE mark
The VIVHEART EasyCross device is intended for patients candidate to TAVR of a native valve recrossing and balloon post-dilation of a prosthetic aortic valve or a valve-in-valve aortic valve replacement The suitability of the patient is to be verified case by case by the specialized physician by means of proper physical examination and instrumental evaluation according to clinical practice
EasyCross device is a catheter is intended to allow a rapid and safe centering of a heart valve in order to direct and introduce a guidewire through it The intended purpose is the use of the device during percutaneous TAVR procedures including TAVR of a native valve recrossing and balloon post-dilation of a prosthetic aortic valve or a valve-in-valve aortic valve replacement within the scope of the CE mark
The VIVHEART EasyCross device is intended for patients candidate to TAVR of a native valve recrossing and balloon post-dilation of a prosthetic aortic valve or a valve-in-valve aortic valve replacement The suitability of the patient is to be verified case by case by the specialized physician by means of proper physical examination and instrumental evaluation according to clinical practice
Study Oversight
Has Oversight DMC:
None
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?:
None