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Recruiting NCT04735003

Transcatheter Interventions for Tricuspid Insufficiency in Italy

— Observational Tricuspid Valve Insufficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcatheter tricuspid valve interventions.
Who it may be relevant to
Registry conditions: Tricuspid Valve Insufficiency. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

TRans-catheter Interventions for triCuspid Valve Insufficiency: the iTalian Multicentre Study

Overview

This is an observational, multi-center, retrospective and prospective study collecting data about patients undergoing transcatheter tricuspid valve interventions in a real world clinical environment. The aim is to report clinical characteristics, procedural results and short- and long-term outcomes of patients undergoing transcatheter tricuspid valve interventions in Italian centres.

Interventions

  • Device Transcatheter tricuspid valve interventions
    Transcatheter repair or replacement to treat tricuspid regurgitation

Primary outcome measures

  • All-cause death [Time frame: 1-year]
  • Cardiovascular death or heart failure hospitalization [Time frame: 1-year]
Secondary outcome measures (9)
  • Changes in tricuspid regurgitation degree [Time frame: 30-day, 1-year and 5-year]
  • Changes in NYHA class [Time frame: 30-day, 1-year and 5-year]
  • Changes in right ventricular dimensions and function [Time frame: 30-day, 1-year and 5-year]
  • Changes in liver and kidney function [Time frame: 30-day, 1-year and 5-year]
  • Changes in medical therapy (i.e. diuretic dose) [Time frame: 30-day, 1-year and 5-year]
  • All-cause death [Time frame: 30-day]
  • All-cause death [Time frame: 5-year]
  • Cardiovascular death or heart failure hospitalization [Time frame: 30-day]
  • Cardiovascular death or heart failure hospitalization [Time frame: 5-year]

Eligibility criteria

Inclusion criteria

  • Patients undergoing transcatheter treatment of tricuspid regurgitation (native valve -with or without previous surgical valve repair - or degenerated bioprosthesis)
  • Patients who are willing and capable of providing informed consent, and participating in all follow-ups associated with this clinical investigation.

Exclusion criteria

  • Valve anatomy unsuitable for transcatheter tricuspid valve interventions.
  • Subjects who are unable or not willing to complete follow-up visits and examination for the duration of the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Marianna Adamo — Brescia

Identifiers

NCT: NCT04735003 · 581011977013

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗