Transcatheter Interventions for Tricuspid Insufficiency in Italy

Tricuspid Valve Insufficiency Clinical Trial

— TRIC-IT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04735003
• Other study ID #: 581011977013
• Status: Recruiting
• Start date: January 30, 2021
• Est. completion date: January 30, 2027

Study information

• Verified date: January 2021
• Source: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
• Contact: Marianna Adamo
• Phone: +390303995564
• Email: mariannaadamo[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 30, 2027
• Est. primary completion date: January 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tricuspid Valve Insufficiency

Intervention

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

Locations

Country	Name	City	State
Italy	Marianna Adamo	Brescia	Lombardia

Sponsors (2)

Lead Sponsor	Collaborator
Marianna Adamo	San Raffaele University Hospital, Italy

Country where clinical trial is conducted

Italy, 

Outcome

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