Klinikum der LMU Muenchen
Munich, Germany
Location status: Recruiting
Location contact
Jörg Hausleiter
CONTACT
NCT Number: NCT04653428
Multicentre observational study of patients with severe tricuspid regurgitation and interventional treatment.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Munich, Germany
Location status: Recruiting
Jörg Hausleiter
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Interventional treatment for tricuspid regurgitatin with CE-certified products, e.g. edge-to-edge repair
Time frame: 1 year
All-cause death and heart failure hospitalisation 1 year after transcatheter tricuspid valve treatment (TTVT)
Time frame: up to 5 years
Long-term all-cause death and heart failure hospitalisation after transcatheter tricuspid valve treatment (TTVT)
Time frame: 30-90 days
Short-term all-cause death and heart failure hospitalisation after transcatheter tricuspid valve treatment (TTVT)
Time frame: up to 5 years
Assessed by echocardiography, tricuspid regurgitation graded on a 4-grade scale.
Time frame: up to 5 years
Assessment for cardiopulmonal symptoms include edema scaling
Time frame: up to 5 years
NYHA classification I, II, III or IV
Time frame: up to 5 years
Assessed by standardized protocol testing 6-minute walking distance
Time frame: up to 5 years
Quality of life is assessed by standardized questionnaires including the Minnesota Living with Heart Failure Questionnaire
Time frame: up to 5 years
N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in pg/ml
Time frame: 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
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Daniel Braun, MD
CONTACT
Jörg Hausleiter, MD
CONTACT
LMU Klinikum
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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