Ignite Creation Date:
2024-05-06 @ 3:51 AM
Last Modification Date:
2024-10-26 @ 11:40 AM
Study NCT ID:
NCT02397668
Status:
RECRUITING
Last Update Posted:
2023-01-26
First Post:
2015-03-06
Brief Title:
CorMatrix Cor TRICUSPID ECM Valve Replacement Study
Sponsor:
CorMatrix Cardiovascular Inc
Organization:
CorMatrix Cardiovascular Inc
Study Overview
Official Title:
CorMatrix Cor TRICUSPID ECM Valve Replacement Safety and Early Feasibility
Status:
RECRUITING
Status Verified Date:
2023-01
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 Pivotal Study of the Cor TRICUSPID ECM Valve or Cor PEDIATRIC Tricuspid ECM Valve This study follows the EFS and is now to determine the safety and efficacy of the Cormatrix Cor TRICUSPID Valve for any patients requiring surgical replacement of the tricuspid valve
Detailed Description:
CorMatrix Cardiovascular Inc has developed a device for heart valve replacement the CorMatrix Cor ECM Tricuspid Valve which can be implanted to replace dysfunctional tricuspid heart valves This Pivotal Study is being performed to verify the ability to successfully implant the Tricuspid Valve the clinical safety of the device and whether the device performs its intended use The study is a multi-center prospective single-arm Pivotal Study of subjects receiving the Cor TRICUSPID ECM Valve or Cor PEDIATRIC Tricuspid ECM Valve The study will be conducted at up to 15 sites
Up to 60 subjects will undergo tricuspid valve replacement TVR with the CorMatrix ECM Valve for the surgical management of tricuspid valve disease The cohort will include up to 60 adult and 18 pediatric patients
Up to 60 subjects will undergo tricuspid valve replacement TVR with the CorMatrix ECM Valve for the surgical management of tricuspid valve disease The cohort will include up to 60 adult and 18 pediatric patients
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