Transcatheter Interventions for Tricuspid Insufficiency in Italy

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04735003

Acronym

TRIC-IT

Enrollment

200

Registered

2021-02-02

Start date

2021-01-30

Completion date

2027-01-30

Last updated

2021-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tricuspid Valve Insufficiency

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.

Interventions

DEVICETranscatheter tricuspid valve interventions

Transcatheter repair or replacement to treat tricuspid regurgitation

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Inclusion criteria

1. Patients undergoing transcatheter treatment of tricuspid regurgitation (native valve -with or without previous surgical valve repair - or degenerated bioprosthesis) 2. Patients who are willing and capable of providing informed consent, and participating in all follow-ups associated with this clinical investigation.

Exclusion criteria

1. Valve anatomy unsuitable for transcatheter tricuspid valve interventions. 2. Subjects who are unable or not willing to complete follow-up visits and examination for the duration of the study.

Design outcomes

Primary

Measure	Time frame
All-cause death	1-year
Cardiovascular death or heart failure hospitalization	1-year

Secondary

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

Countries

Italy

Contacts

Primary ContactMarianna Adamo

mariannaadamo@hotmail.com+390303995564

Backup ContactPaolo Denti

paolodenti@hotmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026