An observational study in Tricuspid Regurgitation, sponsored by Michele De Bonis. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-10.
Sponsored by Michele De Bonis · Observational
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.
219 studies on the registry are indexed under Tricuspid Valve Insufficiency; 106 are open to participants now.
This study's enrollment of 172 is below the median of 200 across 96 observational studies indexed under Tricuspid Valve Insufficiency.
Browse Tricuspid Valve Insufficiency studies →Michele De Bonis is the lead sponsor of 21 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients affected by severe TR, degenerative or functional, requiring isolated (not concomitant with other valvular procedures) repair or replacement of the tricuspid valve
Exclusion Criteria:
Surgical treatment of tricuspid regurgitation, that may be performed by repair or replacement
Mortality
Time frame: Up to 17 years
Reoperation for TR recurrency
Time frame: Up to 17 years
Right heart failure hospitalization incidence
Time frame: Up to 17 years
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Tricuspid Valve Insufficiency→
Michele De Bonis