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

Tricuspid Regurgitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05721417
• Other study ID #: LOITAPF
• Status: Completed
• Start date: February 1, 2022
• Est. completion date: February 12, 2022

Study information

• Verified date: February 2023
• Source: Ospedale San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: February 12, 2022
• Est. primary completion date: February 12, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Procedure:
• Tricuspid valve surgery
Surgical treatment of tricuspid regurgitation, that may be performed by repair or replacement

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Michele De Bonis

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		Up to 17 years
Primary	Reoperation for TR recurrency		Up to 17 years
Primary	Right heart failure hospitalization incidence		Up to 17 years