Transcatheter Interventions for Tricuspid Insufficiency in Italy (TRIC-IT)

January 30, 2021 updated by: Marianna Adamo

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Lombardia
      • Brescia, Lombardia, Italy, 25123
        • Recruiting
        • Marianna Adamo
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marianna Adamo
        • Principal Investigator:
          • Paolo Denti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with significant tricuspid regurgitation who need transcatheter tricuspid valve intervention.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All-cause death
Time Frame: 1-year
1-year
Cardiovascular death or heart failure hospitalization
Time Frame: 1-year
1-year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marianna Adamo

Collaborators

San Raffaele University Hospital, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 30, 2021

Primary Completion (Anticipated)

January 30, 2026

Study Completion (Anticipated)

January 30, 2027

Study Registration Dates

First Submitted

January 16, 2021

First Submitted That Met QC Criteria

January 30, 2021

First Posted (Actual)

February 2, 2021

Study Record Updates

Last Update Posted (Actual)

February 2, 2021

Last Update Submitted That Met QC Criteria

January 30, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 581011977013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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