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Clinical Trials/NCT04735003
NCT04735003
Recruiting
Not Applicable

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

Marianna Adamo1 site in 1 country200 target enrollmentJanuary 30, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tricuspid Valve Insufficiency
Sponsor
Marianna Adamo
Enrollment
200
Locations
1
Primary Endpoint
All-cause death
Status
Recruiting
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 30, 2021
End Date
January 30, 2027
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Marianna Adamo
Responsible Party
Sponsor Investigator
Principal Investigator

Marianna Adamo

Principal investigator

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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.

Outcomes

Primary Outcomes

All-cause death

Time Frame: 1-year

Cardiovascular death or heart failure hospitalization

Time Frame: 1-year

Secondary Outcomes

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

Study Sites (1)

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