Heart Valve, Tricuspid Regurgitation, Tricuspid Valve Insufficiency
Conditions
Keywords
Tricuspid regurgiation, Tricuspid valve insufficiency, Interventional treatment, Heart valve diseases
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.
Interventions
DEVICEInterventional treatment of tricuspid regurgitation
Interventional treatment for tricuspid regurgitatin with CE-certified products, e.g. edge-to-edge repair
Sponsors
Heart and Diabetes Center North Rhine-Westphalia
Heart Center Leipzig - University Hospital
Mainz University
Universitätsklinikum Köln
University Hospital, Essen
LMU Klinikum
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause death and heart failure hospitalisation | 1 year | All-cause death and heart failure hospitalisation 1 year after transcatheter tricuspid valve treatment (TTVT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause death and heart failure hospitalisation (long-term) | up to 5 years | Long-term all-cause death and heart failure hospitalisation after transcatheter tricuspid valve treatment (TTVT) |
| All-cause death and heart failure hospitalisation (short-term) | 30-90 days | Short-term all-cause death and heart failure hospitalisation after transcatheter tricuspid valve treatment (TTVT) |
| Change of tricuspid regurgitation after transcatheter tricuspid valve treatment (TTVT) | up to 5 years | Assessed by echocardiography, tricuspid regurgitation graded on a 4-grade scale. |
| Change of cardiopulmonal symptoms after transcatheter tricuspid valve treatment (TTVT) | up to 5 years | Assessment for cardiopulmonal symptoms include edema scaling |
| Change of 6-minute walking distance test after transcatheter tricuspid valve treatment (TTVT) | up to 5 years | Assessed by standardized protocol testing 6-minute walking distance |
| Change of quality of life after transcatheter tricuspid valve treatment (TTVT) | up to 5 years | Quality of life is assessed by standardized questionnaires including the Minnesota Living with Heart Failure Questionnaire |
| Change of NT-proBNP after transcatheter tricuspid valve treatment (TTVT) | up to 5 years | N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in pg/ml |
| Procedural success after transcatheter tricuspid valve treatment (TTVT) | At the day of discharge 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 |
| Change of NYHA classification after transcatheter tricuspid valve treatment (TTVT) | up to 5 years | NYHA classification I, II, III or IV |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety outcome after transcatheter tricuspid valve treatment (TTVT) | At the day of discharge 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. |
Countries
Germany
Contacts
Primary ContactJörg Hausleiter, MD
Backup ContactDaniel Braun, MD
Outcome results
None listed