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CompletedNCT05721417Updated Feb 10, 2023

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

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

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
172
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Tricuspid Regurgitation
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In context

Tricuspid Valve Insufficiency

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 →

Lead sponsor

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.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients affected by severe TR, degenerative or functional, requiring isolated (not concomitant with other valvular procedures) repair or replacement of the tricuspid valve

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

Exclusion Criteria:

  • Patients with non-isolated tricuspid valve surgery (concomitant surgery on other valves).
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
172 participants (actual)
Patient registry
No

Interventions

  • ProcedureTricuspid valve surgery

    Surgical treatment of tricuspid regurgitation, that may be performed by repair or replacement

06

What researchers measure

Primary outcomes

  1. Mortality

    Time frame: Up to 17 years

  2. Reoperation for TR recurrency

    Time frame: Up to 17 years

  3. Right heart failure hospitalization incidence

    Time frame: Up to 17 years

07

Study locations

1 site
  • IRCCS Ospedale San Raffaele
    Milan, 20132, Italy
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05721417
Lead sponsor
Michele De Bonis
Responsible party
Michele De Bonis (Chief of Cardiac Surgery of Advanced and Research Therapies, Ospedale San Raffaele) — Sponsor-investigator
First posted
Feb 10, 2023
Start date
Feb 1, 2022
Primary completion
Feb 12, 2022
Completion
Feb 12, 2022
Last update
Feb 10, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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