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

Sponsor
Michele De Bonis (Other)
Overall Status
Completed
CT.gov ID
NCT05721417
Collaborator
(none)
172
1
11
475.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Tricuspid valve surgery

Study Design

Study Type:
Observational
Actual Enrollment :
172 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Long-term Outcomes of Isolated Tricuspid Valve Surgery According to Preoperative Clinical and Functional Staging
Actual Study Start Date :
Feb 1, 2022
Actual Primary Completion Date :
Feb 12, 2022
Actual Study Completion Date :
Feb 12, 2022

Outcome Measures

Primary Outcome Measures

  1. Mortality [Up to 17 years]

  2. Reoperation for TR recurrency [Up to 17 years]

  3. Right heart failure hospitalization incidence [Up to 17 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 IRCCS Ospedale San Raffaele Milan Italy 20132

Sponsors and Collaborators

  • Michele De Bonis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michele De Bonis, Chief of Cardiac Surgery of Advanced and Research Therapies, Ospedale San Raffaele
ClinicalTrials.gov Identifier:
NCT05721417
Other Study ID Numbers:
  • LOITAPF
First Posted:
Feb 10, 2023
Last Update Posted:
Feb 10, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 10, 2023