Clinical Trials Logo

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05721417
Study type Observational
Source Ospedale San Raffaele
Contact
Status Completed
Phase
Start date February 1, 2022
Completion date February 12, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT05434507 - Feasibility Study of Treating Tricuspid Regurgitation With K-ClipTM Transcatheter Annuloplasty System N/A
Completed NCT03144024 - Comparison of Rigid Annuloplasty Ring With a Band in the Correction of Secondary Tricuspid Insufficiency N/A
Enrolling by invitation NCT05825898 - Outcome of Patients With Severe Functional TR According to Medical, Transcatheter or Surgical Treatment
Completed NCT05836493 - Very Long-term (>15 Years) Results of Tricuspid Valve Repair.
Enrolling by invitation NCT06033274 - Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment
Recruiting NCT05671640 - Feasibility Study of the DragonFly-T System for Severe Tricuspid Regurgitation N/A
Recruiting NCT06027307 - Enavogliflozin Outcome Trial in Functional Tricuspid Regurgitation Phase 3
Terminated NCT04665583 - Prehab Prior to Undergoing Tricuspid Intervention
Recruiting NCT06307262 - European Registry of Transcatheter Repair for Tricuspid Regurgitation
Completed NCT02981953 - TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System N/A
Recruiting NCT04433065 - TTVR Early Feasibility Study N/A
Not yet recruiting NCT05556460 - Safety and Effectiveness Study of DragonFly-T System for Severe Tricuspid Regurgitation N/A
Recruiting NCT05667519 - Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation (PLACE) N/A
Recruiting NCT04653428 - German Registry for Transcatheter Tricuspid Valve Interventions
Recruiting NCT05179616 - Pforzheim Tricuspid Valve Registry - Outcomes of Percutaneous Tricuspid Valve Repair
Completed NCT02644616 - The Safety and Efficacy of Tolvaptan for Patients With Tricuspid Regurgitation and Right Heart Failure After Left Heart Valves Replacement Phase 4
Recruiting NCT05328284 - PASCAL for Tricuspid Regurgitation - a European Registry
Completed NCT02675244 - Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery N/A
Recruiting NCT05436028 - A Study to Evaluate the Safety and Performance of LuX-Valve Plus System for Tricuspid Replacement N/A
Completed NCT01093001 - Tricuspid Regurgitation Study Phase 4