Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06591000
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Clinical Efficacy and Long-term Outcomes of ALLOgraft Versus Stented Biological Prosthesis for Primary TRIcuspid Valve Disease ALLOTRI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Efficacy and Long-term Outcomes of Allograft Versus Stented Biological Prosthesis for Primary Tricuspid Valve Disease
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study is to evaluate early safety clinical efficacy and long-term outcomes of mitral allografts and stented biological prosthesis in tricuspid valve replacement for primary tricuspid valve diseases
Detailed Description:
Early safety morbidity mortality rate freedom from any valve related complication along with clinical efficacy survival freedom from reoperation repeat endocarditis and other valve related complication long term outcomes survival freedom from reoperation repeat endocarditis and other valve related complication echocardiografic assessment and MSCT scan for both groups of patients are going to be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None