German Registry for Transcatheter Tricuspid Valve Interventions
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Tricuspid Regurgitation
- Sponsor
- LMU Klinikum
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- All-cause death and heart failure hospitalisation
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
Multicentre observational study of patients with severe tricuspid regurgitation and interventional treatment.
Detailed Description
Severe tricuspid regurgitation occurs in around 1.5 % of men and 5.6 % of women and it is associated with significant morbidity and mortality. Current guidelines recommend cardiac surgery, especially in those patients who are undergoing left side valve surgery. Nevertheless many patients are not eligible for surgical tricuspid valve repair due to an high risk of mortality. Therefore interventional devices for treatment of tricuspid regurgitation have been established to offer these patients an alternative treatment option. The aim of this study is to analyse the success and saftey aspects of different interventional repair techniques for severe tricuspid regurgitation. Therefore in this prospectively designed observational study clinical, echocardiographic and laboratory parameters will be collected.
Investigators
Prof. Dr. med. Jörg Hausleiter
Professor
LMU Klinikum
Eligibility Criteria
Inclusion Criteria
- •Interventional treatment of severe tricuspid regurgitation (isolated or in combination with another interventional treatment) with a CE certified product for tricuspid valve repair
- •Informed consent corresponding to criteria of Good Clinical Practice and the decleration of Helsinki as well as to standards of the local ethic commission.
Exclusion Criteria
- •No agreement to participation
- •Age \< 18 years
Outcomes
Primary Outcomes
All-cause death and heart failure hospitalisation
Time Frame: 1 year
All-cause death and heart failure hospitalisation 1 year after transcatheter tricuspid valve treatment (TTVT)
Secondary Outcomes
- Change of 6-minute walking distance test after transcatheter tricuspid valve treatment (TTVT)(up to 5 years)
- Change of NYHA classification after transcatheter tricuspid valve treatment (TTVT)(up to 5 years)
- Change of NT-proBNP after transcatheter tricuspid valve treatment (TTVT)(up to 5 years)
- Procedural success after transcatheter tricuspid valve treatment (TTVT)(At the day of discharge after transcatheter tricuspid valve treatment (TTVT))
- All-cause death and heart failure hospitalisation (long-term)(up to 5 years)
- Change of quality of life after transcatheter tricuspid valve treatment (TTVT)(up to 5 years)
- All-cause death and heart failure hospitalisation (short-term)(30-90 days)
- Change of cardiopulmonal symptoms after transcatheter tricuspid valve treatment (TTVT)(up to 5 years)
- Change of tricuspid regurgitation after transcatheter tricuspid valve treatment (TTVT)(up to 5 years)