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| Name | Class |
|---|---|
| Heart and Diabetes Center North Rhine-Westphalia | OTHER |
| Heart Center Leipzig - University Hospital | OTHER |
| Mainz University | OTHER |
| Universitätsklinikum Köln |
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Multicentre observational study of patients with severe tricuspid regurgitation and interventional treatment.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interventional treatment of tricuspid regurgitation | Device | Interventional treatment for tricuspid regurgitatin with CE-certified products, e.g. edge-to-edge repair |
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety outcome after transcatheter tricuspid valve treatment (TTVT) | The saftety outcome contains all complications which occur between the interventional treatment of the tricuspid regurgitation and discharge from the hospital. Data collection includes: mortality with differentiation of cardiac death and non-cardiac death, unplanned cardiac surgery, re-intervention of tricuspid valve, pericardial tamponade, intervention of coronary arteries. Moreover major adverse events as defined by MVARC2 criteria are recorded at discharge from hospital: death with differentiation of cardiac death and non-cardiac death, peri-procedural or spontaneous myocardial infarction, stroke, transient ischemic attack, life-threatening, major or minor bleeding, acute kidney failure, complications of the vascular access. |
Inclusion Criteria:
Exclusion Criteria:
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Patients with severe symptomatic tricuspid regurgitation, who are not eligible for cardiac surgery due to a high risk of mortality.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jörg Hausleiter, MD | Contact | +49 89 4400 72361 | joerg.hausleiter@med.uni-muenchen.de | |
| Daniel Braun, MD | Contact | +4915254848306 | daniel.braun@med.uni-muenchen.de |
| Name | Affiliation | Role |
|---|---|---|
| Jörg Hausleiter, MD | Klinikum der LMU Muenchen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum der LMU Muenchen | Recruiting | Munich | Germany |
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| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| OTHER |
| University Hospital, Essen | OTHER |
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Blood sample
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) |
| At the day of discharge after transcatheter tricuspid valve treatment (TTVT) |