NCT05721417

Long-term Outcomes of Isolated Tricuspid Valve Surgery According to Preoperative Clinical and Functional Staging

Michele De Bonis·ClinicalTrials.gov·procedureCompleted
View on ClinicalTrials.gov
Study focus
Disease/Condition
Tricuspid Regurgitation
Drug/Device/Intervention
Tricuspid valve surgery
Study type
Observational
Intervention type
procedure
Sponsor & location
Primary sponsor
Michele De Bonis
Funder
Ospedale San Raffaele
Location
Milan, Italy
Timeline & enrollment
Phase
N/A
Start date
Feb 01, 2022
End date
Feb 12, 2022
Enrollment
172 participants
Primary outcome

Mortality,Reoperation for TR recurrency,Right heart failure hospitalization incidence

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.

ICD-10 classifications
Tricuspid stenosisTricuspid stenosis with insufficiencyNonrheumatic tricuspid (valve) stenosisTricuspid insufficiencyNonrheumatic tricuspid (valve) stenosis with insufficiency
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05721417
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05721417 through Pure Global AI's free database. This phase not specified trial is sponsored by Michele De Bonis and is currently Completed. The study focuses on Tricuspid Regurgitation. Target enrollment is 172 participants.

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