German Registry for Transcatheter Tricuspid Valve Interventions

Study Overview
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Brief Summary
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Multicentre observational study of patients with severe tricuspid regurgitation and interventional treatment.

Detailed Description
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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.

Official Title
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German Registry for Transcatheter Tricuspid Valve Interventions

Conditions
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Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Heart Valve

Intervention / Treatment
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* Device: Interventional treatment of tricuspid regurgitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Interventional treatment of tricuspid regurgitation|Interventional treatment for tricuspid regurgitatin with CE-certified products, e.g. edge-to-edge repair|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause death and heart failure hospitalisation | All-cause death and heart failure hospitalisation 1 year after transcatheter tricuspid valve treatment (TTVT) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause death and heart failure hospitalisation (long-term) | Long-term all-cause death and heart failure hospitalisation after transcatheter tricuspid valve treatment (TTVT) | up to 5 years | 
| All-cause death and heart failure hospitalisation (short-term) | Short-term all-cause death and heart failure hospitalisation after transcatheter tricuspid valve treatment (TTVT) | 30-90 days | 
| Change of tricuspid regurgitation after transcatheter tricuspid valve treatment (TTVT) | Assessed by echocardiography, tricuspid regurgitation graded on a 4-grade scale. | up to 5 years | 
| Change of cardiopulmonal symptoms after transcatheter tricuspid valve treatment (TTVT) | Assessment for cardiopulmonal symptoms include edema scaling | up to 5 years | 
| Change of NYHA classification after transcatheter tricuspid valve treatment (TTVT) | NYHA classification I, II, III or IV | up to 5 years | 
| Change of 6-minute walking distance test after transcatheter tricuspid valve treatment (TTVT) | Assessed by standardized protocol testing 6-minute walking distance | up to 5 years | 
| Change of quality of life after transcatheter tricuspid valve treatment (TTVT) | Quality of life is assessed by standardized questionnaires including the Minnesota Living with Heart Failure Questionnaire | up to 5 years | 
| Change of NT-proBNP after transcatheter tricuspid valve treatment (TTVT) | N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in pg/ml | up to 5 years | 
| Procedural success after transcatheter tricuspid valve treatment (TTVT) | Procedural success is defined as a reduction of the tricuspid regurgitation to at least grade 2+ achieved by interventional treatment | At the day of discharge after transcatheter tricuspid valve treatment (TTVT) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tricuspid regurgiation, Tricuspid valve insufficiency, Interventional treatment, Heart valve diseases