Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 11:34 PM
Study NCT ID:
NCT05836493
Status:
COMPLETED
Last Update Posted:
2023-05-01
First Post:
2023-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Very Long-term (>15 Years) Results of Tricuspid Valve Repair.
Sponsor:
Michele De Bonis
Organization:
Study Overview
Official Title:
Very Long-term (>15 Years) Results of Tricuspid Valve Repair.
Status:
COMPLETED
Status Verified Date:
2023-04
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:
Interest in Tricuspid valve disease grew exponentially in the last years in response to an increased awareness of the poor outcome of patients with functional Tricuspid Regurgitation (TR). Earlier reports advocated for a more conservative TR management in patients undergoing left-sided heart valve surgery but more recent guidelines advised for a more aggressive TR management, as accumulating evidence demonstrates its adverse impact on long term morbidity and mortality. Several papers have been published analyzing the results of surgical tricuspid valve repair but the length of the follow-up is usually limited to 10 to 12 years. With this study the investigators aim to analyze the very long-term results (\>15years) of tricuspid valve repair according to the surgical method employed for valve repair (suture vs ring annuloplasty).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: