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Long-term Outcomes of Isolated Tricuspid Valve Surgery According to Preoperative Clinical and Functional Staging - Trial NCT05721417

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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NCT05721417
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Trial Details
ClinicalTrials.gov โ€ข NCT05721417
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Long-term Outcomes of Isolated Tricuspid Valve Surgery According to Preoperative Clinical and Functional Staging

Study Focus

Tricuspid Regurgitation

Tricuspid valve surgery

Observational

procedure

Sponsor & Location

Michele De Bonis

Ospedale San Raffaele

Milan, Italy

Timeline & Enrollment

N/A

Feb 01, 2022

Feb 12, 2022

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 stenosis
Tricuspid stenosis with insufficiency
Nonrheumatic tricuspid (valve) stenosis
Tricuspid insufficiency
Nonrheumatic tricuspid (valve) stenosis with insufficiency

Data Source

ClinicalTrials.gov

NCT05721417

Non-Device Trial