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Clinical Trials/NCT05721417
NCT05721417
Completed
N/A

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

Michele De Bonis1 site in 1 country172 target enrollmentFebruary 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Tricuspid Regurgitation
Sponsor
Michele De Bonis
Enrollment
172
Locations
1
Primary Endpoint
Mortality
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2022
End Date
February 12, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Michele De Bonis

Chief of Cardiac Surgery of Advanced and Research Therapies

Ospedale San Raffaele

Eligibility Criteria

Inclusion Criteria

  • Adult patients
  • Affected by severe tricuspid regurgitation (TR), both of degenerative and functional etiology and;
  • Patients underwent isolated surgery, either repair or replacement, of the tricuspid valve
  • Patients operated on at theCardiac Surgery Department of San Raffaele Hospital from May 2004 to May 2020.

Exclusion Criteria

  • Patients with non-isolated tricuspid valve surgery (concomitant surgery on other valves).

Outcomes

Primary Outcomes

Mortality

Time Frame: Up to 17 years

Right heart failure hospitalization incidence

Time Frame: Up to 17 years

Reoperation for TR recurrency

Time Frame: Up to 17 years

Study Sites (1)

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