Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05721417
Status:
COMPLETED
Last Update Posted:
2023-02-10
First Post:
2023-01-30
Brief Title:
Long-term Outcomes of Isolated Tricuspid Valve Surgery According to Preoperative Clinical and Functional Staging
Sponsor:
Michele De Bonis
Organization:
Ospedale San Raffaele
Study Overview
Official Title:
Long-term Outcomes of Isolated Tricuspid Valve Surgery According to Preoperative Clinical and Functional Staging
Status:
COMPLETED
Status Verified Date:
2023-02
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:
Tricuspid regurgitation TR was identified as an independent prognostic factor associated with excess mortality and morbidity independent of left ventricular LV function and pulmonary hypertension Isolated tricuspid surgery has been performed for a long time in a few selected cases however in recent years several studies have underlined how the poor outcomes described for isolated tricuspid valve surgery seem to be related to the baseline characteristics of the patients and to late referral for surgical treatment rather than the intervention itself To facilitate patient screening a new clinical and functional TR staging system has recently been proposed This classification which evaluates the progression of morphological variations of the tricuspid valve and right ventricle RV in association with the onset of symptoms identifies several parameters and factors that can be useful for a better stratification of surgical risk Rather than simply assessing the degree of TR this new staging mechanism also focuses on symptoms RV remodeling and function medical therapy and right heart failure hospitalizations
Investigators previously focused on the short-term mainly hospital outcomes of patients undergoing isolated surgery for severe TR who were classified at baseline according to this clinical and functional staging system Results showed that a more comprehensive classification reflects the population and hospital outcomes of surgically treated patients with isolated TR
The purpose of this study is to ultimately evaluate long-term outcomes of this patients population and estimate the impact of baseline staging on long-term outcomes
Investigators previously focused on the short-term mainly hospital outcomes of patients undergoing isolated surgery for severe TR who were classified at baseline according to this clinical and functional staging system Results showed that a more comprehensive classification reflects the population and hospital outcomes of surgically treated patients with isolated TR
The purpose of this study is to ultimately evaluate long-term outcomes of this patients population and estimate the impact of baseline staging on long-term outcomes
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None