Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05742906
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2023-01-30
Brief Title:
CorMatrix Cor TRICUSPID ECM Valve Replacement - Pivotal Study
Sponsor:
CorMatrix Cardiovascular Inc
Organization:
CorMatrix Cardiovascular Inc
Study Overview
Official Title:
CorMatrix Cor TRICUSPID ECM Valve Replacement Study
Status:
RECRUITING
Status Verified Date:
2024-03
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 goal of this pivotal study is to demonstrate the safety and performance of the Cor TRICUSPID ECM extracellular matrix Valve or Cor PEDIATRIC Tricuspid ECM Valve for the surgical management of tricuspid valve disease and dysfunction in adult and pediatric patients The main questions it aims to answer are
whether the device may be implanted successfully and safely and
whether the device effectively treats tricuspid valve disease and dysfunction through 12 months
Participants will undergo
preoperative evaluation
tricuspid valve replacement with the Cor TRICUSPID ECM Valve
postoperative evaluation including at hospital discharge 30 days 6 months and 12 months and then annually thereafter through 5 years
whether the device may be implanted successfully and safely and
whether the device effectively treats tricuspid valve disease and dysfunction through 12 months
Participants will undergo
preoperative evaluation
tricuspid valve replacement with the Cor TRICUSPID ECM Valve
postoperative evaluation including at hospital discharge 30 days 6 months and 12 months and then annually thereafter through 5 years
Detailed Description:
CorMatrix Cardiovascular Inc has developed a device for heart valve replacement the Cor TRICUSPID ECM Valve for adults and the Cor PEDIATRIC Tricuspid ECM Valve for pediatrics collectively these devices will be referred to as the Cor TRICUSPID ECM Valves which can be implanted to replace dysfunctional tricuspid heart valves The objective of this Pivotal Study is to collect safety and effectiveness data on surgical tricuspid valve replacement procedures using the Cor TRICUSPID ECM valve to support a Humanitarian Device Exemption HDE marketing application
Because the majority of tricuspid valve replacements TVRs approximately 80 are performed concomitantly with other cardiac operations including replacements of mitral or aortic valves it is anticipated that a portion of study subjects will require concomitant replacement or repair of a dysfunctional mitral or aortic valve based on the clinical judgment of the investigator
Therefore safety with the Cor TRICUSPID ECM Valve will be established by Procedural Technical and Device Success
Because the majority of tricuspid valve replacements TVRs approximately 80 are performed concomitantly with other cardiac operations including replacements of mitral or aortic valves it is anticipated that a portion of study subjects will require concomitant replacement or repair of a dysfunctional mitral or aortic valve based on the clinical judgment of the investigator
Therefore safety with the Cor TRICUSPID ECM Valve will be established by Procedural Technical and Device Success
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?:
False
Is an FDA AA801 Violation?:
None