Transcatheter Interventions for Tricuspid Insufficiency in Italy
Recruiting
- Conditions
- Tricuspid Valve Insufficiency
- Registration Number
- NCT04735003
- Lead Sponsor
- Marianna Adamo
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All-cause death 1-year Cardiovascular death or heart failure hospitalization 1-year
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Marianna Adamo
🇮🇹Brescia, Lombardia, Italy