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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04735003
Recruitment Status : Recruiting
First Posted : February 2, 2021
Last Update Posted : February 2, 2021
Sponsor:
Collaborator:
San Raffaele University Hospital, Italy
Information provided by (Responsible Party):
Marianna Adamo, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Study Description
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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.

Condition or disease Intervention/treatment
Tricuspid Valve Insufficiency Device: Transcatheter tricuspid valve interventions

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: TRans-catheter Interventions for triCuspid Valve Insufficiency: the iTalian Multicentre Study
Estimated Study Start Date : January 30, 2021
Estimated Primary Completion Date : January 30, 2026
Estimated Study Completion Date : January 30, 2027
Groups and Cohorts
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Intervention Details:
  • Device: Transcatheter tricuspid valve interventions
    Transcatheter repair or replacement to treat tricuspid regurgitation

Outcome Measures
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Primary Outcome Measures :
  1. All-cause death [ Time Frame: 1-year ]
  2. Cardiovascular death or heart failure hospitalization [ Time Frame: 1-year ]

Secondary Outcome Measures :
  1. Changes in tricuspid regurgitation degree [ Time Frame: 30-day, 1-year and 5-year ]
  2. Changes in NYHA class [ Time Frame: 30-day, 1-year and 5-year ]
  3. Changes in right ventricular dimensions and function [ Time Frame: 30-day, 1-year and 5-year ]
  4. Changes in liver and kidney function [ Time Frame: 30-day, 1-year and 5-year ]
  5. Changes in medical therapy (i.e. diuretic dose) [ Time Frame: 30-day, 1-year and 5-year ]
  6. All-cause death [ Time Frame: 30-day ]
  7. All-cause death [ Time Frame: 5-year ]
  8. Cardiovascular death or heart failure hospitalization [ Time Frame: 30-day ]
  9. Cardiovascular death or heart failure hospitalization [ Time Frame: 5-year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with significant tricuspid regurgitation who need transcatheter tricuspid valve intervention.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04735003


Contacts
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Contact: Marianna Adamo +390303995564 mariannaadamo@hotmail.com
Contact: Paolo Denti paolodenti@hotmail.com

Locations
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Italy
Marianna Adamo Recruiting
Brescia, Lombardia, Italy, 25123
Contact: Marianna Adamo    +390303995564    mariannaadamo@hotmail.com   
Contact: Paolo Denti       paolodenti@hotmail.com   
Principal Investigator: Marianna Adamo         
Principal Investigator: Paolo Denti         
Sponsors and Collaborators
Marianna Adamo
San Raffaele University Hospital, Italy
More Information
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Responsible Party: Marianna Adamo, Principal investigator, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
ClinicalTrials.gov Identifier: NCT04735003    
Other Study ID Numbers: 581011977013
First Posted: February 2, 2021    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases