NCT04735003
Recruiting
Not Applicable
TRans-catheter Interventions for triCuspid Valve Insufficiency: the iTalian Multicentre Study
Marianna Adamo1 site in 1 country200 target enrollmentJanuary 30, 2021
ConditionsTricuspid Valve Insufficiency
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tricuspid Valve Insufficiency
- Sponsor
- Marianna Adamo
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- All-cause death
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
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.
Investigators
Marianna Adamo
Principal investigator
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
All-cause death
Time Frame: 1-year
Cardiovascular death or heart failure hospitalization
Time Frame: 1-year
Secondary Outcomes
- Changes in medical therapy (i.e. diuretic dose)(30-day, 1-year and 5-year)
- Changes in right ventricular dimensions and function(30-day, 1-year and 5-year)
- All-cause death(5-year)
- Changes in liver and kidney function(30-day, 1-year and 5-year)
- Changes in tricuspid regurgitation degree(30-day, 1-year and 5-year)
- Changes in NYHA class(30-day, 1-year and 5-year)
- Cardiovascular death or heart failure hospitalization(5-year)
Study Sites (1)
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