Transcatheter Interventions for Tricuspid Insufficiency in Italy
TRIC-IT
TRans-catheter Interventions for triCuspid Valve Insufficiency: the iTalian Multicentre Study
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2021
CompletedStudy Start
First participant enrolled
January 30, 2021
CompletedFirst Posted
Study publicly available on registry
February 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2027
ExpectedFebruary 2, 2021
January 1, 2021
5 years
January 16, 2021
January 30, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
All-cause death
1-year
Cardiovascular death or heart failure hospitalization
1-year
Secondary Outcomes (9)
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
- +4 more secondary outcomes
Interventions
Transcatheter repair or replacement to treat tricuspid regurgitation
Eligibility Criteria
Patients with significant tricuspid regurgitation who need transcatheter tricuspid valve intervention.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Marianna Adamolead
- San Raffaele University Hospital, Italycollaborator
Study Sites (1)
Marianna Adamo
Brescia, Lombardy, 25123, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
January 16, 2021
First Posted
February 2, 2021
Study Start
January 30, 2021
Primary Completion
January 30, 2026
Study Completion (Estimated)
January 30, 2027
Last Updated
February 2, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share