Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458907
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-07
Brief Title:
TRICAV-II Pivotal TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation
Sponsor:
PF Products Features USA Inc
Organization:
PF Products Features USA Inc
Study Overview
Official Title:
A Prospective Multicenter Randomized Clinical Trial of the TricValve Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation TR
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
TRICAV-II
Brief Summary:
The Investigational Device is the TricValve Transcatheter Bicaval Valve System also referred to as the TricValve System
The bioprosthesis is available in two different diameters for each model SVC and IVC specifically designed to adapt to the anatomic features of the superior vena cava SVC and inferior vena cava IVC
The SVC and IVC valves are single use sterile devices provided in two sizes each for a total of four valve sizes The valves are designed for heterotopic caval implantation without perturbing the native tricuspid valve The valves are made of bovine pericardium leaflets sutured on a nitinol self-expanding stent system
The SVC and IVC valves are provided pre-mounted in two separate TricValve Delivery Systems and are individually packaged into two separate boxes provided sterile and ready to use The two TricValve Delivery Systems deliver the two valves percutaneously into the SVC and IVC via femoral vein access using a transvenous approach
The bioprosthesis is available in two different diameters for each model SVC and IVC specifically designed to adapt to the anatomic features of the superior vena cava SVC and inferior vena cava IVC
The SVC and IVC valves are single use sterile devices provided in two sizes each for a total of four valve sizes The valves are designed for heterotopic caval implantation without perturbing the native tricuspid valve The valves are made of bovine pericardium leaflets sutured on a nitinol self-expanding stent system
The SVC and IVC valves are provided pre-mounted in two separate TricValve Delivery Systems and are individually packaged into two separate boxes provided sterile and ready to use The two TricValve Delivery Systems deliver the two valves percutaneously into the SVC and IVC via femoral vein access using a transvenous approach
Detailed Description:
This is a prospective multi-center randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the TricValve System with Optimal Medical Therapy OMT compared to OMT alone in the treatment of patients with severe TR and caval reflux CR
The TricValve System received Breakthrough Device Designation from the US FDA
The TricValve System received Breakthrough Device Designation from the US FDA
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?:
None
Is an FDA AA801 Violation?:
None