German Registry for Transcatheter Tricuspid Valve Interventions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Interventional treatment of tricuspid regurgitation.
- Who it may be relevant to
- Registry conditions: Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Heart Valve. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Interventional treatment of tricuspid regurgitation
Interventional treatment for tricuspid regurgitatin with CE-certified products, e.g. edge-to-edge repair
Primary outcome measures
- All-cause death and heart failure hospitalisation [Time frame: 1 year]
Secondary outcome measures (9)
- All-cause death and heart failure hospitalisation (long-term) [Time frame: up to 5 years]
- All-cause death and heart failure hospitalisation (short-term) [Time frame: 30-90 days]
- Change of tricuspid regurgitation after transcatheter tricuspid valve treatment (TTVT) [Time frame: up to 5 years]
- Change of cardiopulmonal symptoms after transcatheter tricuspid valve treatment (TTVT) [Time frame: up to 5 years]
- Change of NYHA classification after transcatheter tricuspid valve treatment (TTVT) [Time frame: up to 5 years]
- Change of 6-minute walking distance test after transcatheter tricuspid valve treatment (TTVT) [Time frame: up to 5 years]
- Change of quality of life after transcatheter tricuspid valve treatment (TTVT) [Time frame: up to 5 years]
- Change of NT-proBNP after transcatheter tricuspid valve treatment (TTVT) [Time frame: up to 5 years]
- Procedural success after transcatheter tricuspid valve treatment (TTVT) [Time frame: At the day of discharge after transcatheter tricuspid valve treatment (TTVT)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Klinikum der LMU Muenchen — Munich
Identifiers
NCT: NCT04653428 · D-TRIK